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Sr Manager Regulatory Affairs

ConfidentialMumbai, India

8 days ago

Job description

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

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Skills Required

Documentation Management, regulatory intelligence , Regulatory Submissions, labelling , regulatory documentation

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