Sr Manager Regulatory Affairs

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