Assistant Manager – Technical Regulatory Affairs

JOB RESPONSIBILTIES

• Review product formulations for compliance with Indian FDA regulations (Cosmetics & Ayurvedic), EU Cosmetics Regulation (EC No. 1223/2009), GSO, and GCC guidelines.
• Prepare, review, and maintain Product Information Files (PIFs), including safety assessments, to meet domestic and international export requirements.
• Review product labels, ingredient declarations, and marketing claims to ensure compliance with country-specific regulatory requirements.
• Prepare and maintain Safety Data Sheets (SDS) in accordance with applicable export regulations.
• Monitor and interpret changes in global regulatory requirements and proactively communicate updates and impacts to internal stakeholders.
• Coordinate with the Design team to develop and approve product labels in alignment with country-specific regulatory standards.
• Collaborate with R&D, Quality Assurance, and Raw Material Procurement teams to ensure regulatory compliance across product development and sourcing.
• Provide regulatory guidance to R&D during new product development to ensure global regulatory acceptance and market readiness.
• Maintain accurate regulatory records, documentation, and databases for all export and domestic product formulations.
• Manage and execute new regulatory projects and certifications, including ECOCERT, COSMOS, and Organic Cosmetics certifications.
• Handle product formulation documentation, submissions, and approvals with the FDA, Uttarakhand.
• Execute regulatory compliance activities for new and existing products in the Indian market and export territories.

ACADEMIC QUALIFICATION

• Master’s degree in Pharmacy, Chemistry, or Toxicology.

WORK EXPERIENCE & SKILL SETS

• Minimum 5-7 Years of experience in Technical Regulatory affairs, preferably in Ayurvedic / Cosmetics / Personal care sector.
• Knowledge of the latest updated Rules/versions of - Legal Metrology (Packaged Commodities) Rules, 2011, Drugs and Cosmetics Act,1940, and Rules, 1945, Cosmetics Rule 2020.
• Knowledge of EU Cosmetics Regulation (EC 1223/2009 and export documentation processes.
• In-depth knowledge of ingredient compliance, restricted/prohibited substances, and regulatory evaluation of formulations as per Indian and EU regulations.