106 Regulatory Affairs Specialist jobs in Mumbai

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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:

Contact Us

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.

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.

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.

• 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.

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.

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.