Regulatory Affairs Manager

 

Role Summary: The Regulatory Compliance & Advocacy Manager will lead and oversee regulatory compliance and advocacy initiatives for the organization, ensuring alignment with food regulations in India and overseas for export. With a strong focus on regulatory compliance, policy interpretation, and stakeholder advocacy, the role involves building robust strategies to support the company’s objectives while maintaining strict adherence to the Food Safety and Standards Authority of India (FSSAI) guidelines and other regulatory frameworks. The candidate should have minimum 10 to 12 years of experience in regulatory affairs with a deep understanding of food laws, regulations, its impact on the business and should be able to represent the organization in discussions with government, regulatory bodies and trade chambers.

Key Responsibilities:

1. Regulatory Compliance Leadership:
   • Develop and implement strategies to ensure the company’s food products comply with the Food Safety and Standards Act, 2006, and related regulations.
   • Ensure compliance with regulatory requirements across the product lifecycle, including product development, manufacturing, marketing, and distribution.
   • Review and approve product labels, packaging, claims, and advertisements to meet FSSAI guidelines and relevant BIS standards.
2. Regulatory Advocacy:
   • Act as the company’s representative in discussions with FSSAI, BIS, Ministry of Health, and other regulatory bodies to influence and shape policy changes.
   • Build strong relationships with key stakeholders, including industry associations, policymakers, academia and government officials, to advocate for the company’s interests.
   • Monitor and contribute to public consultations, policy drafts, and amendments issued by regulatory authorities to ensure alignment with business objectives.
3. Stakeholder Collaboration and Representation:
   • Collaborate with internal departments (R&D, Quality Assurance, Legal, Marketing, Sourcing, Supply Chain) to ensure compliance and alignment with regulatory requirements.
   • Represent the company at regulatory forums, industry conferences, and workshops to stay informed and contribute to industry-level discussions.
4. Risk Assessment and Crisis Management:
   • Identify potential regulatory risks and develop strategies to mitigate them.
   • Lead the resolution of compliance-related issues, including responding to notices or inquiries from regulatory authorities.
   • Develop crisis management plans for addressing regulatory non-compliance or adverse findings.
5. Team Management and Training:
   • Lead, mentor, and manage a team of regulatory affairs professionals, ensuring effective execution of regulatory strategies.
   • Conduct training programs to enhance regulatory knowledge and awareness across the organization.
6. Regulatory Intelligence:
   • Monitor global and domestic regulatory changes, emerging trends, and technological advancements in food safety and compliance.
   • Conduct periodic regulatory audits and provide updates to senior management on compliance status and regulatory changes.
7. Documentation and Licensing:
   • Oversee the preparation and submission of regulatory dossiers, applications, and licenses to FSSAI and other authorities.
   • Maintain comprehensive records of regulatory filings, approvals, and correspondence.
8. Travel and On-Site Responsibilities:
   • Travel to manufacturing units, regulatory offices, and industry forums for inspections, advocacy, and compliance activities as needed.