Regulatory Affairs Manager

Job Summary:

FDA (U.S.), EFSA (EU), FSSAI (India)

Key Responsibilities:

Regulatory Strategy & Compliance.

• Develop and implement regulatory strategies for product launches and market expansions.
• Ensure the certifications are renewed on time and also apply for new certifications in new geographies.
• Interpret and apply country-specific regulations (FDA/DSHEA, EFSA, FSSAI, etc.) to ensure compliance.

Dossier & Documentation Management.

• Prepare and maintain regulatory submissions, including product dossiers, GRAS documentation, and ingredient justifications.
• Ensure technical files and records (safety data, clinical support for claims, specifications) are audit-ready.

Labelling, Claims & Marketing Review.

• Review and approve labels, packaging, and marketing materials for regulatory compliance.
• Evaluate substantiation for health and structure/function claims to ensure legal acceptability.

Cross-functional Collaboration

• Collaborate with R&D, Quality, Marketing, and Legal teams to align product development with regulatory requirements.
• Provide regulatory support during product lifecycle management and reformulations.

Regulatory Liaison

• Act as the point of contact with national and international regulatory agencies (e.g., FDA, EFSA, FSSAI, TGA).
• Lead the response to agency inquiries, inspections, or compliance reviews.

Training & Risk Management

• Provide internal training on new regulations and compliance procedures.
• Identify and mitigate regulatory risks associated with ingredients, claims, or labelling.

Required Qualifications:

• Bachelor's or Master’s degree in Pharmacy, Food Science, Chemistry, Life Sciences, or a related discipline.
• 5+ years of experience in regulatory affairs in the

  nutraceutical

  ,

  dietary supplement

  , or

  functional foods

  sector.
• Strong knowledge of international regulatory frameworks:

  FDA/DSHEA (U.S.), EFSA (EU), FSSAI (India)

  .
• Familiarity with Codex Alimentarius and GMP guidelines preferred.
• Excellent written and verbal communication skills.
• Attention to detail and experience handling complex documentation.

Preferred Experience:

• Experience with digital regulatory platforms or document management systems.
• Experience interacting directly with regulatory authorities or participating in audits/inspections.
• Regulatory submissions for new ingredients, import/export regulatory support.