Job Title: Assistant Manager - Regulatory Affairs
Competencies
Purpose of Job
Skill Required
Roles and 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 Required
M.Pharm ( RA / QA )
Relevant skills / Industry experience
10-15 Years in Regulatory/ Compliance Related Activities
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Plasma Fractionation Unit, Ahm, GJ, IN, 382210