Regulatory Affairs

Mumbai, Maharashtra ₹900000 - ₹1200000 Y CliniLaunch Research Institute

Posted today

Job Viewed

Tap Again To Close

Job Description

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).

Location: Andheri, Mumbai.

Qualification: M. Pharm. (Experienced preferred).

JOB DESCRIPTION – Regulatory Affairs (Domestic)

The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with

experience in FDA related activities. This profile will ensure timely and robust functional/cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution

and implementation of regulatory affairs and safety processes.

Local Regulatory Function (Licensing):

  • Prepare registration dossier for procuring certificates/license from local FDA, DCGI and
  • FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs
  • & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.
  • Confirm product formula and label acceptability, as well as the receipt of necessary licenses,
  • prior to the release of product.
  • Co-ordinate with QC and R&D departments for technical documents (manufacturing
  • documents like batch records, specifications, analytical methods, validation reports, and
  • stability data) required to be incorporated in the registration dossiers.
  • Ensure timely renewal of drug and food licenses maintained by head office and also branch
  • offices based at various states in the country.
  • Online application for obtaining test license for import purpose.
  • Maintain archival of all regulatory permissions.
  • Keep abreast of the updates pertaining to regulatory requirements and accordingly
  • implement them.
  • Prepare responses to the legal & technical queries raised by the Regulatory authorities.

Compliance of Packaging Modules:

  • Formulate and implement statutory requirements pertaining to the artworks of the
  • products (label, carton, package insert, patient information leaflet, etc.).
  • Review the artwork of all packaging material.
  • Prepare package insert as per New Drugs and Clinical Trials Rules 2019.
  • Pharmacovigilance
  • Provide high quality medical writing from planning and coordination of literature research.
  • Draft and review PSURs with focus on medical aspects of the products and safety sections.
  • Review of Risk Management Plans as per Regulatory requirement.
  • Good knowledge in assessing the risk-benefit of a product and identify any gaps in the
  • aggregate documents.
  • Perform scientific review of aggregate reports / ICSRs produced by PV Associates.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs

Mumbai, Maharashtra ₹500000 - ₹1500000 Y Win in Life Academy

Posted today

Job Viewed

Tap Again To Close

Job Description

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).

Location: Andheri, Mumbai.

Qualification: M. Pharm. (Experienced preferred).

Experience- 1-5 Years

JOB DESCRIPTION – Regulatory Affairs (Domestic)

The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with

experience in FDA related activities. This profile will ensure timely and robust functional/cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution

and implementation of regulatory affairs and safety processes.

Local Regulatory Function (Licensing):

· Prepare registration dossier for procuring certificates/license from local FDA, DCGI and

· FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs

· & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.

· Confirm product formula and label acceptability, as well as the receipt of necessary licenses,

· prior to the release of product.

· Co-ordinate with QC and R&D departments for technical documents (manufacturing

· documents like batch records, specifications, analytical methods, validation reports, and

· stability data) required to be incorporated in the registration dossiers.

· Ensure timely renewal of drug and food licenses maintained by head office and also branch

· offices based at various states in the country.

· Online application for obtaining test license for import purpose.

· Maintain archival of all regulatory permissions.

· Keep abreast of the updates pertaining to regulatory requirements and accordingly

· implement them.

· Prepare responses to the legal & technical queries raised by the Regulatory authorities.

Compliance of Packaging Modules:

· Formulate and implement statutory requirements pertaining to the artworks of the

· products (label, carton, package insert, patient information leaflet, etc.).

· Review the artwork of all packaging material.

· Prepare package insert as per New Drugs and Clinical Trials Rules 2019.

· Pharmacovigilance

· Provide high quality medical writing from planning and coordination of literature research.

· Draft and review PSURs with focus on medical aspects of the products and safety sections.

· Review of Risk Management Plans as per Regulatory requirement.

· Good knowledge in assessing the risk-benefit of a product and identify any gaps in the

· aggregate documents.

· Perform scientific review of aggregate reports / ICSRs produced by PV Associates.

This advertiser has chosen not to accept applicants from your region.

Dir Regulatory Affairs

Navi Mumbai, Maharashtra Teva Pharmaceuticals

Posted 6 days ago

Job Viewed

Tap Again To Close

Job Description

Dir Regulatory Affairs
Date: Sep 20, 2025
Location:
Navi Mumbai, India,
Company: Teva Pharmaceuticals
Job Id: 63035
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
The Director, Regulatory Affairs - Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U.S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key liaison with the FDA, internal stakeholders, and external partners.
**How you'll spend your day**
+ Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations.
+ Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences
+ Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams.
+ Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc.
+ Establish and maintain strong relationships with FDA project managers.
+ Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes.
+ Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization.
+ Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning.
+ Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives.
+ Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book.
**Your experience and qualifications**
+ Pharm Dor M. Pharma in a scientific discipline.
+ Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products.
+ Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains.
+ Deep expertise and applied knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
+ Experience with regulatory systems (e.g., Veeva, TrackWise) and electronic document management systems (e.g. Wisdom, Glorya, Livelink, Knowledgetree).
+ Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs.
+ Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance.
+ Demonstrates a basic understanding of pharmaceutical drug development.
+ Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills.
+ Demonstrates excellent verbal and written communication skills.
+ Experience working in a matrixed, multinational environment, as well as with third parties.
+ Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus.
+ Lean Six Sigma certification, or other accreditation related to improving business processes is a plus.
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran
This advertiser has chosen not to accept applicants from your region.

Manager Regulatory Affairs

Mumbai, Maharashtra Abbott

Posted 9 days ago

Job Viewed

Tap Again To Close

Job Description

**Key Accountabilities :**
Propose efficient regulatory pathway for New Product Introduction
 Develop & implement regulatory strategies for new/generic product registrations in
compliance with relevant regulations and the business needs
Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.
related to new products filing
ollaborate with other functions such as R&D, Quality, Supply chain, Project
Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with
business priorities
esponsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to
CDSCO (Central Drugs Standard Control Organization), State FDA etc.
ell versed with filing application of ND/SND/FDC/Import Registration/Import licence
etc on SUGAM portal
ddress queries from CDSCO/SFDA on submitted applications, provide regulatory
support for IPC/CDTL/CDL testing
anage submission of application dossiers with relevant regulatory authorities, monitor
the review process and take appropriate actions to obtain regulatory approvals as planned.
esponsible for Subject expert committee (SEC) meetings including preparation of slide
deck in co-ordination with cross functional teams and SEC deliberation
Track all SEC meetings to identify and recommend new product ideas/opportunities
aligned with current business needs
rovide Regulatory Support for timely new product launches
Minimum Education:
M. Pharm/B. Pharm
Minimum Experience Required:
8-10 years
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.

Associate, Regulatory Affairs

Mumbai, Maharashtra Colgate-Palmolive

Posted 10 days ago

Job Viewed

Tap Again To Close

Job Description

Relocation Assistance Offered Within Country
Job Number # - Mumbai, Maharashtra, India
**Who We Are**
Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!
Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values-Caring, Inclusive, and Courageous-we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.
**Brief introduction - Role Summary/Purpose :**
+ This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.Engage proactively with diverse cross-functional teams, including R&D, legal, regulatory, and marketing departments, to meticulously develop and rigorously review all ingredient lists. This collaborative effort is crucial to guarantee the utmost accuracy and comprehensiveness of each list, ensuring full compliance with all relevant regulations and internal company standards. The objective is to achieve complete alignment across all stakeholders, from initial concept to final product launch, preventing discrepancies and ensuring transparency.
**Responsibilities:**
+ Responsible for developing/reviewing accurate and comprehensive ingredient lists while collaborating closely with cross-functional stakeholders to ensure alignment and timely updates. Manage and maintain a detailed tracking system to monitor ingredient list status, changes and requirements, facilitating smooth communication and efficient project progress.
+ Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
+ Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
+ Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies.
+ Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
+ Update and maintain product registration and ingredients archives, databases and tracking tools.
+ Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products eg cosmetics, home care, consumer goods.
+ Work closely with Global and third party business partners to obtain the relevant documents and information for product dossiers.
+ Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
+ Manage the distribution lists of SOP and the archiving in the documentation system.
Artwork Approval:
+ Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (e.g. INCI and INDI).
+ Assist the Regional Regulatory Affairs managers with artwork review and approval
Regulatory intelligence and product advocacy activities:
+ Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
+ Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
+ Track Competent Authority websites and databases for news related to new product registrations.
+ Assist Regional Regulatory team to deliver and manage Regulatory Assessment
**Required Qualifications :**
+ BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
+ Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
+ Understanding of registration and regulatory requirements in Africa Eurasian and Asia Pacific countries.
+ Knowledge of industry practices, techniques and standards.
+ Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.
**Preferred Qualifications:**
+ Good written and verbal communicator with excellent interpersonal skills.
+ Good planning and organizing skills.
+ Ability to work under stress and meet deadlines.
+ Fluency in spoken and written English is mandatory.
+ Fluency in languages is advantageous.
#CPIL #LI-AP1
**Our Commitment to Inclusion**
Our journey begins with our people-developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business.
**Equal Opportunity Employer**
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form ( should you require accommodation.
#LI-Hybrid
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Associate

Navi Mumbai, Maharashtra Peoplefy

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

Hi Everyone,

I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.


Please refer below JD and share your profile on


  • Experienced in preparing, review and compile regulatory submissions.
  • Maintain compliance with US FDA and ICH requirements.
  • Should have experienced in pre-submission activity.
  • Experienced in CMC.
  • Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.
  • Maintain compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines.
  • Author and review high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS).
  • Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact.
  • Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data.
  • Support regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses.
  • Review and approve change controls from global manufacturing partners to assess regulatory impact.
  • Stay current with FDA guidance, ICH regulations, pharmacopeial requirements, and industry updates.

Thank you!

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Associate

Navi Mumbai, Maharashtra Peoplefy

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Regulatory consulting agencies Jobs in Mumbai !

Associate, Regulatory Affairs

Mumbai, Maharashtra ₹104000 - ₹130878 Y Colgate-Palmolive

Posted today

Job Viewed

Tap Again To Close

Job Description

Relocation Assistance Offered Within Country

Job Number # Mumbai, Maharashtra, India

Who We Are

Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name

Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.

Brief introduction - Role Summary/Purpose :

  • This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.Engage proactively with diverse cross-functional teams, including R&D, legal, regulatory, and marketing departments, to meticulously develop and rigorously review all ingredient lists. This collaborative effort is crucial to guarantee the utmost accuracy and comprehensiveness of each list, ensuring full compliance with all relevant regulations and internal company standards. The objective is to achieve complete alignment across all stakeholders, from initial concept to final product launch, preventing discrepancies and ensuring transparency.

Responsibilities:

  • Responsible for developing/reviewing accurate and comprehensive ingredient lists while collaborating closely with cross-functional stakeholders to ensure alignment and timely updates. Manage and maintain a detailed tracking system to monitor ingredient list status, changes and requirements, facilitating smooth communication and efficient project progress.
  • Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
  • Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
  • Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies.
  • Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
  • Update and maintain product registration and ingredients archives, databases and tracking tools.
  • Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products eg cosmetics, home care, consumer goods.
  • Work closely with Global and third party business partners to obtain the relevant documents and information for product dossiers.
  • Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
  • Manage the distribution lists of SOP and the archiving in the documentation system.

Artwork Approval:

  • Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (e.g. INCI and INDI).
  • Assist the Regional Regulatory Affairs managers with artwork review and approval

Regulatory intelligence and product advocacy activities:

  • Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
  • Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
  • Track Competent Authority websites and databases for news related to new product registrations.
  • Assist Regional Regulatory team to deliver and manage Regulatory Assessment

Required Qualifications :

  • BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
  • Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
  • Understanding of registration and regulatory requirements in Africa Eurasian and Asia Pacific countries.
  • Knowledge of industry practices, techniques and standards.
  • Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.

Preferred Qualifications:

  • Good written and verbal communicator with excellent interpersonal skills.
  • Good planning and organizing skills.
  • Ability to work under stress and meet deadlines.

  • Fluency in spoken and written English is mandatory.

  • Fluency in languages is advantageous.
CPIL #LI-AP1

Our Commitment to Inclusion

Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business.

Equal Opportunity Employer

Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation.

LI-Hybrid
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs-CMC

Navi Mumbai, Maharashtra ₹900000 - ₹1200000 Y Peoplefy Infosolutions

Posted today

Job Viewed

Tap Again To Close

Job Description

We're Hiring: Regulatory Affairs CMC Associate

Location: Navi Mumbai

Years of Experience:4+ years

Work from Office

Notice Period: Looking for immediate joiners

Skills Required:

Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.

4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting.

Strong experience in US FDA regulations and ICH guidelines.

Experience in handling pre- and post-approval submissions is required

Interested candidates can share their resumes on

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Executive

Mumbai, Maharashtra ₹900000 - ₹1200000 Y Illusion Dental Laboratory

Posted today

Job Viewed

Tap Again To Close

Job Description

Job Title: Regulatory Affairs

No of Vacancy: 1

Job Location: Andheri West

Years of Experience: 1-4 years

Working Days: Monday to Saturday

Job Summary:

We are seeking a motivated and detail-oriented
Regulatory Affairs Executive
to join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU. This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions.

Key Responsibilities:

Conduct
gap analysis
of existing regulatory and technical documentation.

Prepare and maintain regulatory submissions including:

l Device Master Files

l Risk Management Files

l Design History Files

l Clinical Evaluation Reports

l Usability Reports

Draft and update product labeling content such as
Instructions for Use (IFUs)
,
implant cards
, and
declarations
to meet global compliance requirements.

Support
regulatory submissions
for India (via CDSCO/SUGAM/NSWS), US (FDA), EU (CE marking under MDR), and other applicable markets.

Coordinate with cross-functional teams including
Purchase, Accounts, Legal, Marketing
, and
R&D
to gather documentation and resolve queries.

Assist in preparing and submitting responses for
audit-related queries
and regulatory inspections.

Contribute to regulatory strategy for
new product developments
and modifications.

Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training.

Educational Qualifications:

Bachelor's or Master's degree in
Pharmaceutical Sciences
,
Engineering
,
Biotechnology
,
Microbiology
, or a related life science field.

Specialization in
Regulatory Affairs
or
Quality Assurance
preferred.

Experience:

1 to 4 years
of industry experience in a Regulatory Affairs role, preferably in medical devices, pharmaceuticals, or life sciences.

Hands-on experience with global and domestic regulatory submissions.

Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential.

Experience or knowledge of
software regulations
is an added advantage.

Key Skills and Competencies:

Strong knowledge of:

Regulatory frameworks
including ISO 13485, EU MDR, and 21 CFR Part 820

Risk management
,
design controls
, and
post-market surveillance

Excellent
documentation, analytical
, and
technical writing skills

Proficient in
Microsoft Office Suite
and digital documentation platforms

Strong interpersonal skills to collaborate with internal departments and external bodies

Soft Skills:

Go-getter attitude
with the willingness to lead and take initiative

High
English proficiency
– both verbal and written

Strong
organizational
and
time management
skills

Ability to work independently and as part of a
cross-functional team.

Fast learner with a proactive mindset for continuous development.

Monday to Saturday working

This advertiser has chosen not to accept applicants from your region.

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Regulatory Consulting Agencies Jobs View All Jobs in Mumbai