Assistant Manager - Regulatory Affairs

Job Description:

Responsibilites

• Domestic regulatory filing and approval. Submission of registration dossier/s as per MOH requirements initially in countries, to explore further in different markets as per managements decision. Review/Gap analysis of the existing versus US/EU regulations & dossiers as per ICH guidelines, country specific requirements.
• Maintain current knowledge of relevant regulations for registrations in International markets.
• Coordinate with regulatory activities such as international audits & regulatory agency inspections, product recalls.
• Planning dossier submission timelines in coordination with QA.

Qualification & Experience

• M.Pharm ( RA / QA )
• Relevant Skills / Industry Experience
• 10-15 Years in Regulatory/ Compliance Related Activities