Assistant Manager Regulatory Affairs

5 - 9 years

0 Lacs

Posted:4 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As an Assistant Manager in Regulatory Affairs at our Haridwar factory, your role will focus on Technical Regulatory Affairs in the Personal Care - Cosmetics/Ayurvedic industry. You will report to the Head of QA & QC and be responsible for the following key activities: - Reviewing product formulations in compliance with Indian FDA (Cosmetics & Ayurvedic) regulation, EU Cosmetics Regulation (EC 1223/2009), US FDA, ASEAN, and GCC guidelines. - Preparing and maintaining regulatory dossiers such as Product Information Files (PIF) and safety assessments as per export requirements. - Ensuring product labels, ingredient lists, and claims adhere to country-specific regulations. - Preparing Products Safety Data Sheet according to export regulations. - Staying updated on changing regulations and communicating updates to stakeholders. - Collaborating with the Design team to create labels that meet country-specific regulations. - Coordinating with R&D, Quality Assurance, and RM procurement teams for regulatory requirements. - Providing regulatory guidance to R&D for new product development to ensure global market acceptance. - Maintaining accurate records, documentation, and regulatory databases for all export product formulations. In terms of qualifications, we are looking for someone with: - A Master's degree in Pharmacy or Chemistry. - Knowledge of global cosmetic regulations and export documentation processes. - Familiarity with regulatory portals and international submission formats. Ideally, you should have a minimum of 5-7 years of experience in Technical Regulatory Affairs, preferably in the Ayurvedic, Cosmetics, or Personal Care sector. Join us in our commitment to regulatory compliance and product safety as we strive to meet global quality standards in the personal care industry.,

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