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.