Regulatory Affairs Manager

6 days ago

Varanasi, India Ixoreal Biomed Full time

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 of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal Extracts, Functional Foods, or Pharma (with strong exposure to nutraceutical regulations). Strong background in compiling and reviewing 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: The Global Regulatory Affairs Manager will oversee all regulatory compliance activities related to the company’s nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., 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.

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