91 Senior Regulatory Affairs Manager jobs in Mumbai

Key Roles and Responsibilities:

Regulatory Compliance & Licensing:

• Lead and manage all regulatory approvals, licensing, and registration activities across relevant regulatory authorities to ensure timely approvals (FSSAI, Tea Board of India, MSME, Factory License, Trade License, etc.).
• Develop and oversee robust systems for regulatory compliance reporting (e.g., Whistleblower avenues).
• Establish and implement compliance frameworks aligned with food safety and regulatory guidelines.
• Provide proactive strategic advice on regulatory matters across domains including Health, Safety, Environment, Food Safety, Pollution Control, Customs, and Product Liability.
• Ensure up-to-date renewals and compliance for all essential business licenses across group companies and associates.
• Ensure full compliance with FSSAI and Legal Metrology standards across all products and packaging.
• Continuously monitor, interpret, and implement changes to food regulations (especially FSSAI updates).

Stakeholder Management & Coordination:

• Establish and manage an effective stakeholder engagement matrix with central/state authorities.
• Liaise with regulatory bodies, consultants, and local agencies for licensing processes, issue resolution, and standard implementation.
• Maintain all necessary documentation and ensure readiness for regulatory review or inspections.

Quality Control & Food Safety:

• Coordinate with QC teams to ensure internal and external product testing complies with FSSR and other regulatory standards.
• Lead regulatory and food safety activities for India and international markets to ensure product compliance.
• Drive the resolution of product safety issues and customer complaints through testing, analysis, and action.

Product Labelling & Trademark Compliance:

• Validate and ensure accuracy of product labelling for compliance with Indian and international regulations (e.g., USFDA, EU).
• Collaborate with marketing and design teams for creation and approval of compliant labels and packaging artwork.
• Maintain and manage barcode databases and ensure labelling readiness for retail and export.
• Coordinate with external agencies for application, renewal, and protection of trademarks. Review legal drafts for oppositions/counter-statements and provide required documentation.

Regulatory Audits:

• Develop internal control systems and monitor adherence through regular and surprise audits at plant, warehouse, and store levels.
• Create and execute quarterly/half-yearly audit plans; lead both internal and external audit activities.
• Identify process gaps and risks, present findings to management, and drive corrective actions.
• Maintain weekly/monthly compliance trackers and provide updates to senior leadership.
• Collaborate with HODs and external auditors to ensure full statutory, regulatory, and client compliance.

Required Skills & Qualifications:

• Bachelor’s Degree in Nutrition, Food Science, or Nutraceuticals (Mandatory)
• Master’s Degree in Nutraceuticals (Preferred)
• In-depth knowledge of Nutraceutical NPD , regulatory affairs, FSSAI, Legal Metrology, and international food regulations.

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.

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.

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.

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.

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.

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.

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.