Regulatory Affairs Manager

5 days ago

Mumbai, India Wellbeing Nutrition Full time

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.

  • Regulatory Affairs Manager

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 14,40,000 - ₹ 21,60,000

    Job Title: Regulatory Affairs ManagerAbout the RoleThis is an exciting opportunity for a highly skilled Regulatory Affairs professional to join our organization and contribute to the success of our team. We are seeking an experienced Regulatory Affairs Executive to lead our regulatory strategy, manage regulatory submissions, and maintain strong relationships...

  • Regulatory Affairs Manager

    6 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Regulatory Affairs Manager - Submission Publishing Job DescriptionJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to lead our submission publishing efforts. As a key member of our team, you will be responsible for delivering high-quality submissions while ensuring compliance with global health authority requirements.Key...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Pithampur, India Gepach International Full time US$ 80,000 - US$ 1,20,000 per year

    Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.1. Dossier Preparation and ReviewOversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time

    Job DescriptionPosition: 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 withexperience in FDA related activities. This profile...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 30,00,000

    Job OverviewThe Manager of Regulatory Affairs will be a specialist professional with comprehensive knowledge in the area of regulatory affairs.Main Responsibilities:Develop and manage product registration submissions, progress reports, supplements, amendments, or periodic experience reports as a highly experienced and knowledgeable resource within the...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    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 withexperience in FDA related activities. This profile will ensure...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...

  • Regulatory Affairs

    1 day ago

    Mumbai, India CliniLaunch Research Institute Full time

    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...

  • Regulatory Affairs

    1 day ago

    Mumbai, India Win in Life Academy Full time

    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....

  • Required Regulatory Affairs

    1 week ago

    Mumbai, Maharashtra, India NOVO Medi Sciences Pvt ltd Full time ₹ 7,00,000 - ₹ 9,00,000 per year

    Required Regulatory Affairs | Chembur Salary: Job Title: Regulatory Affairs Location: Chembur Key Responsibilities: Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa. Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance. MOH Query Response:...