Assistant Manager Regulatory Affairs

JOB TITLE- ASSISTANT MANAGER (REGULATORY AFFAIRS)

DEPARTMENT- REGULATORY AFFAIRS

INDUSTRY- PERSONAL CARE - COSMETICS / AYURVEDIC

LOCATION- HARIDWAR FACTORY

ROLE- TECHNICAL REGULATORY AFFAIRS

REPORTS TO HEAD QA & QC

RESPONSIBILITIES :

Review Product formulation as per Indian FDA (Cosmetics & Ayurvedic) regulation, EU Cosmetics Regulation (EC 1223 / 2009), US FDA, ASEAN, and GCC guidelines.

Prepare and maintain regulatory dossiers as Product Information Files (PIF), and safety assessments as per Export requirements.

Review product labels, ingredient lists, and claims to ensure adherence to country-specific regulations.

Preparation of the Product’s Safety Data Sheet as per export regulations.

Keep track of changing regulations and update stakeholders accordingly.

Coordinate with the Design team to develop Labels as country-specific regulations.

Coordinate with R&D, Quality Assurance, and RM procurement team for regulatory requirements.

Provide regulatory input to R&D during new product development to ensure global market acceptance.

Maintain proper records, documentation, and regulatory databases for all export product formulations.

ACADEMIC QUALIFICATION :

Master’s degree in Pharmacy / Chemistry

Knowledge of global cosmetic regulations and export documentation processes.

Familiarity with regulatory portals and international submission formats.

WORK EXPERIENCE :

Minimum 5-7 Years of experience in Technical Regulatory affairs, preferably in Ayurvedic / Cosmetics / Personal care sector.