Regulatory Affairs Manager

About the Company:

Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.

Title: Manager/Senior Manager- Global Regulatory Affairs

Experience:

8–12+ years

Technical Dossiers:

Ingredient dossiers

Regulatory compliance documents

Safety and toxicology data

Stability data

Label claim substantiation

Salary: As per the Market Standards

Location: Shri Kartikeya Pharma, 3rd Floor, PBN Centre, Road No:45, Jubilee Hills, Hyderabad-500033

Purpose of the Role:

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

Key Deliverables:

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.