Upgrad rekrut
Location
Mumbai | India
Job description
Job Title: Group Leader - Regional Regulatory Affairs European Market - MODULE 1
Qualification: M. Pharm/ B Pharma
Experience: 8 + years (5 years min in European market )
Responsibilities :
Have at least 6 year experience managing regulatory activities for EU market. This experience should include Module 1 compilation, artwork requirements & approvals, submission of new Marketing Authorisation.
Contribute to the regulatory strategy by participating in the team discussion and providing regulatory input as per the current guidelines during the initial phase of development till the submission of the dossier to ensure correct documentation and data generation
Review of the submission and associated documents as per the current regulatory requirement to ensure the correctness of the same for compliance with the regulatory health authorities requirement of filing
Maintain the market authorisation throughout the product life cycle to ensure the compliance to product quality and safety and by renewing validity/ submitting annual report to ensure availability of the product in market
ยท Maintain validity of the marketing authorisation by filing renewal/Annual report (US) to ensure availability of product for placing in market
Maintain the data base associated with the DOS by including all the details in the database for ease of product history.
If Interested please share resume at [HIDDEN TEXT]
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