142 Senior Regulatory Affairs Manager jobs in Mumbai
Regulatory Affairs Manager
Posted today
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End-to-end management of regulatory submissions for finished dosage forms. Prepare & compile high-quality dossiers (Modules 1–5). Coordinate cross-functional teams, handle queries, ensure compliance, and support lifecycle mgmt of products.
Regulatory Affairs Specialist
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Job Description
About the Role
Seeking an experienced
Manager – Regulatory Affairs
to lead regulatory strategy, submissions, and compliance for our product portfolio. The ideal candidate will have strong knowledge of
Indian and global regulatory frameworks
and proven experience in managing dossiers, approvals, and compliance with authorities like
CDSCO, FDA, DCGI, and FSSAI
.
Key Responsibilities
- Develop and implement
regulatory strategies
for new and existing products. - Prepare, review, and file
dossiers, NDAs, notifications, and submissions
with regulatory bodies. - Ensure ongoing compliance with
GMP, GCP, labeling, and advertising standards
. - Maintain and update
regulatory documentation
(technical files, safety dossiers, product registrations). - Liaise with
regulatory authorities (CDSCO, State FDA, DCGI, port offices)
for approvals and queries. - Collaborate cross-functionally with
R&D, QA, Marketing, and Legal
teams to ensure compliance throughout the product lifecycle. - Lead regulatory support for
audits, inspections, and certifications
. - Monitor
global regulatory updates (FSSAI, FDA, EU, ASEAN, GCC, NAFDAC)
and assess impact on the business. - Oversee
post-market regulatory management
including change control, reporting, and recalls.
Qualifications
- Bachelor's / Master's degree in
Pharma, Regulatory Affairs, Food Science, Chemistry, or Life Sciences
. - 5–10 years' experience
in Regulatory Affairs (Pharma, Nutraceuticals, Food, or Healthcare). - Strong knowledge of
Indian & international regulations
(FSSAI, FDA, DSHEA, FSMA, EU). - Experience in
product submissions, NDAs, compliance audits, and dossier management
. - Excellent
analytical, communication, and project management
skills.
Regulatory Affairs Specialist
Posted today
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At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Regulatory Affairs Specialist
POSITION PURPOSE:
- Responsible and accountable for all regulatory affairs activities of Bayer Pharma (PH) within assigned portfolio and/or geography. In alignment with Head of RA PH-South Asia, provide effective functional leadership and governance into planning, developing and executing regulatory strategies within assigned scope, alignment of these with business goals and plans through cross-functional collaboration enabling efficient implementation of growth, brand value
- Scope of regulatory activities includes all licensing related activities (including timely planning and execution of maintenance, change management) for imported products, local products and export markets dealing with the relevant Health Authorities and government bodies in relation to pharmaceuticals (Rx) & medical devices for assigned portfolio and/or geography
- The position will have to consider and balance the business objectives and priorities within assigned portfolio, analyze necessary resource and time allocation, discuss and propose this for alignment with Head of RA PH-South Asia accordingly. The position holder may supervise junior RA staff in managing the Lifecycle Management activities of pharmaceutical portfolio (eg. Renewals, CMCs) when required
- Ensure the best regulatory planning and preparation for all new chemical/biological entities (NCE/NBEs), new indications and line extensions to be registered in the best possible time frame and with the best possible label. Maintains full awareness of all regulatory activities for assigned portfolio and ensures deadlines and performance standards (incl. compliance KPls) are established and met
- Ensure that the assigned portfolio products remain compliant with all relevant regulatory, corporate and legal policies, procedure, practices and local regulations throughout the entire product life cycle. Develop and propose to RA India team standards to monitor and track processes for compliance and governance as best practice sharing for team adoption
- Work closely with relevant local, regional and global stakeholders, cross-functionally and within regulatory affairs, to deliver optimal company outcomes
- Be actively engaged to inspire, motivate, support team members towards functional excellence to meet current and future RA India objectives for assigned portfolio and be seen as value-add business partner
- Ensure maintenance of required licenses for proper functioning of the company, e.g. GMP certificate, manufacturing license (if applicable), special functioning licenses, and provision thereof on request
- To ensure local regulatory processes and procedures reflect current best practice and local regulations
YOUR TASKS AND RESPONSIBILITIES:
- Responsible and accountable for planning, developing and execution of regulatory submissions and approvals in the country for the assigned PH portfolioenabling the achievement of business strategic objectives as well as for ensuring regulatory compliance. Priority setting and flexibility are constantly needed.
- Conduct regulatory probability assessment of approval and HA review milestones to allow optimal business planning
- Operating in a highly regulated environment that is constantly changing, the incumbent provides input and insights for regulatory probability assessments,
anticipating these changes when making probability assessments based on experience and knowledge of the environment
- Within assigned portfolio or projects, build relationships with the Health Authorities and other government bodies, as key customers essential for
achieving business goals. The relationship is based on trust, transparency and partnership
- Maintain compliance with all relevant regulatory requirements with no supply disruption due to lack of regulatory oversight or suboptimal planning
- Supports Head of RA PH-South Asia in development, implementation of processes, SOPs, and systems
- Secure and maintain compliant product licenses, product labelling and participate in promotional material review/approval for products in assigned
portfolio
WHO YOU ARE:
- Post-graduate in Life Sciences (preferably Pharmacy) with minimum of 3 years pharmaceutical industry experience in regulatory affairs with proven track record and experience in health authority interactions and negotiations, end-to-end regulatory submissions and approvals across various therapeutic areas and categories. Demonstrated track record of providing workable solutions to complex regulatory topics.
- In depth understanding of CMC and clinical aspects for regulatory submissions and other licensing requirements in India. Experience with locally manufactured products and export to neighboring countries (eg. Nepal, Bangladesh, Sri Lanka) highly desired
- The successful candidate will have the requisite experience to act as an effective business partner to country commercial organization. Be self-starter with excellent interpersonal and communication skills to facilitate the ability to negotiate and influence others, while dealing with issues which have considerable scientific and regulatory uncertainty
- Have analytical ability to assess complex/ambiguous situations and proactively identify potential issues and future trends and their impact on assigned portfolio. Propose solutions, risk mitigation strategies
- Fluent in English. Excellent communication skills to communicate effectively both orally and in writing to represent Bayer at external meetings and RA India at internal cross-functional and regional/global meetings
- Ability to multi-task without compromising on quality of outcome, compliance. Good project management skills to organize, prioritize and direct diverse activities in a changing environment often under time pressure
- Solid and demonstrated knowledge of all compliance aspects related to the regulatory affairs function, including detailed understanding of the process and policies of the national or agency or extensive experience with a related national health authority
- Global understanding of Regulatory Affairs and India contributes within this. Good working knowledge of regulatory framework in EU, US and International Standards (e.g. ICH, GCP, GMP) highly desired.
YOUR APPLICATION
Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.
Location:
India : Maharashtra : Thane
Division:
Pharmaceuticals
Reference Code:
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Regulatory Affairs Specialist
Posted today
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Job Description
Job Title:
Regulatory Affairs Specialist Med/Pharma (Female)
Location:
Remote
Position Overview:
We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.
Key Responsibilities:
- Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
- Developed and maintained regulatory strategies to support new product development and lifecycle management.
- Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
- Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
- Managed regulatory documentation archives and maintained compliance records for audits and inspections.
Regulatory Affairs Specialist
Posted today
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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 requires strong expertise in the
Drugs & Cosmetics Act and Rules
,
FSSAI regulations
, and
FDA-related activities
. The profile will ensure
timely and robust cross-functional coordination
(R&D, QC, Marketing, Legal, Production, etc.), transparent execution, and effective implementation of
regulatory affairs and safety processes
.
Local Regulatory Function (Licensing):
- Prepare registration dossier for procuring certificates/licenses from
Local FDA, DCGI, FSSAI, and through the Sugam CDSCO portal
. - Thorough familiarity with
FDA, Sugam CDSCO & FSSAI online portals
, Drugs & Cosmetics Act, and its various Schedules (e.g., Sch Y, Sch M, etc.). - Confirm
product formula and label acceptability
, and ensure receipt of necessary licenses prior to product release. - Coordinate with
QC and R&D
for technical documents (batch records, specifications, analytical methods, validation reports, stability data) required for registration dossiers. - Ensure timely
renewal of drug and food licenses
maintained by head office and branch offices across India. - Apply online for obtaining
test licenses for import purposes
through
Sugam CDSCO
. - Maintain archival of all regulatory permissions.
- Keep abreast of
updates in regulatory requirements
and ensure implementation. - Draft
responses to legal & technical queries
raised by Regulatory Authorities.
Compliance of Packaging Modules:
- Formulate and implement
statutory requirements
pertaining to
artworks
(labels, cartons, package inserts, patient information leaflets, etc.). - Review and approve artwork for all packaging material.
- Prepare
package inserts
as per
New Drugs and Clinical Trials Rules 2019
.
Pharmacovigilance:
- Provide high-quality
medical writing
, including planning and coordination of literature research. - Draft and review
PSURs
with a focus on medical aspects and product safety sections. - Review
Risk Management Plans (RMPs)
as per Regulatory requirements. - Assess
risk-benefit profiles
of products and identify gaps in aggregate documents. - Perform
scientific review
of aggregate reports / ICSRs produced by PV Associates.
Regulatory Affairs Specialist
Posted today
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Job Title:
Senior Executive / Assistant Manager – Regulatory Affairs
Location:
Mumbai, India (On-site)
Employment Type:
Full-time | Permanent
Experience Required:
3 to 8 years
Industry:
Chemicals | Pharmaceuticals | Food & Beverages
Job Function:
Legal | Quality Assurance | Regulatory Affairs
Salary: up to 9 LPA
About the Role:
We are hiring for a
Senior Executive / Assistant Manager – Regulatory Affairs
to join a fast-growing organization in the
chemicals and specialty ingredients sector
. The ideal candidate will be responsible for ensuring company-wide compliance with international regulations, certification standards, and internal quality systems.
Key Responsibilities:
- Manage
REACH registrations
for new products across EU, Korea, Turkey, and UK, including tonnage upgrades and compliance letters. - Handle
customer questionnaires
and provide necessary
declarations and certifications
related to products and manufacturing sites. - Oversee renewal documentation for
Halal, Kosher, FSSAI, RSPO, NSF
, and other certifications. - Maintain
water testing reports
,
nutritional analysis
, and manage
FSSAI annual return filings
. - Conduct
internal audits
under
ISO 9001:2015
as a certified internal auditor. - Address documentation requests from
customers and logistics teams
and resolve regulatory queries. - Regularly update company documents,
certificates
, and product declarations via
OneDrive
. - Train new team members on
ISO standards
,
documentation best practices
, and
REACH compliance
. - Contribute to updating company website content (related to regulatory info and certifications).
Qualifications & Skills:
- 3–8 years of experience in
regulatory affairs
,
compliance
, or
quality documentation
. - Strong command over
REACH
,
ISO 9001:2015
,
FSSAI
, and international product certification processes. - Excellent
written and verbal communication
skills. - Strong attention to detail and
documentation management
skills. - Experience in
chemical
,
pharmaceutical
, or
FMCG
industries is a plus. - Working knowledge of tools like
MS Office
,
cloud storage (OneDrive)
, and
online regulatory portals
.
Why Join Us?
- Work in a
fast-growing and export-oriented
chemical manufacturing company. - Gain exposure to
global regulatory frameworks
and international client documentation. - Be part of a
compliance-driven, process-oriented culture
. - Opportunity for career advancement within a growing regulatory department.
How to Apply:
Submit your updated resume. Shortlisted candidates will be contacted for further discussion.
Lead Regulatory Affairs Specialist
Posted 5 days ago
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Responsibilities:
- Develop and execute regulatory strategies for product registration and market approval.
- Prepare, review, and submit regulatory documentation to health authorities worldwide.
- Liaise with regulatory agencies to facilitate communication and resolve issues.
- Monitor and interpret new and existing regulations and guidelines affecting the company's products and operations.
- Provide regulatory guidance and support to cross-functional teams, including R&D, QA, and manufacturing.
- Conduct regulatory intelligence activities to identify emerging trends and potential impacts on the business.
- Manage post-market surveillance and compliance activities.
- Contribute to the development of product labeling and promotional materials to ensure regulatory compliance.
- Lead and mentor junior regulatory affairs staff.
- Participate in internal and external audits related to regulatory compliance.
- Ensure that all regulatory processes are efficient and meet company objectives.
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology) or a related field; advanced degree preferred.
- Minimum of 5-8 years of experience in regulatory affairs within a relevant industry (e.g., pharmaceuticals, medical devices, consumer goods).
- In-depth knowledge of global regulatory requirements and submission processes.
- Proven experience in preparing and submitting regulatory dossiers.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to effectively communicate complex regulatory information.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Proficiency in regulatory information management systems is a plus.
- Demonstrated leadership potential and ability to work effectively in a remote team environment.
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Principal Regulatory Affairs Specialist
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Regulatory Affairs Associate
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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!
Regulatory Affairs Associate
Posted 1 day ago
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