The role includes developing and executing regulatory strategies, compilation and review of regulatory submissions, ensuring product compliance and acting as a key liaison with regulatory agencies. The role requires a deep understanding of regulatory guidelines, strong analytical and communication skills, and the ability to lead cross-functional teams in regulatory environments like pharmaceuticals and Nutraceuticals / Food supplements.
Work Experience: 10yrs - 12yrs
Qualifications: B.Sc. / M.Sc/ B.Pharm
Key Responsibilities:
Submission Management:
Preparation, review and submission of regulatory documentation (e.g., dossiers, applications) to health authorities as below :
- Europe, South Africa, Australia Phillipines,West Africa (Senegal, Ivory Coast etc., for Drug products.
- Handling complementary medicines in Australia ( TGA )
- FSSAI regulations for Nutraceuticals / Food supplements
- FSSAI License Application, Annual return filing and license maintenance
- Global Regulatory filing for Nutraceuticals / Food supplements
- Labelling including SPC's / PIL
- Free sale certificate application
- Test License Application
Import license / Registration for Cosmetics Compliance :
- Ensure products and processes consistently adhere to all relevant national and international regulations and standards.
Regulatory Intelligence:
- Monitor and interpret changes in regulatory legislation and guidelines, providing actionable insights to internal teams and leadership.
Cross-Functional Collaboration:
- Work with R&D, manufacturing, quality assurance, and commercial teams to align product development and lifecycle management with regulatory requirements.
Documentation Management:
- Maintain accurate and comprehensive regulatory databases, files, and records.
Proficiency in Online Portals:
- Ability to navigate and use the FOSCOS, SUGAM portal for application.
Desired Candidate profile:
- In-depth knowledge of regulatory affairs for Drug products , Nutraceuticals / Health Supplements.
- Strong ability to analyze regulatory issues, trouble shooting and develop pragmatic solutions.
- Excellent verbal and written communication skills to effectively interact with regulatory bodies, internal stakeholders and external customers
- Strong organizational skills and the ability to manage multiple priorities and projects simultaneously.
- Working closely with CMO's for regulatory submissions
- Ability to build relationships and work effectively with various internal departments
- In depth knowledge of Labelling (RDA ,Nutritional information , claims etc. in line with FSSAI and International Food agencies like EFSA etc)
- Preparation of labelling in line with the country requirement , review and finalization of artworks
- Tracking of the regulatory submissions, re-registrations, renewals
- Tracking of the FSSAI licenses, timely renewals
- Ensuring that the product is launched and commercialised as per the approved documents.
- Ensuring that any commitments to the Regulatory agencies are timely addressed
