Regulatory Affairs ManagerIxoreal Biomed • Bengaluru, Republic Of India, IN
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Regulatory Affairs Manager
Ixoreal Biomed • Bengaluru, Republic Of India, IN
6 days ago
Job descriptionPrepare 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. Review and approve labels, packaging, and marketing materials for regulatory compliance. Evaluate substantiation for health and structure / function claims to ensure legal acceptability. 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. 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 Provide internal training on new regulations and compliance procedures. Identify and mitigate regulatory risks associated with ingredients, claims, or labelling. 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.
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.
Labelling, Claims & Marketing Review.
Cross-functional Collaboration
Regulatory Liaison
Training & Risk Management
Required Qualifications :
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Manager Regulatory • Bengaluru, Republic Of India, IN
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