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 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 :