Global Regulatory Affairs Manager

VaudFixeChimie, Pharma, Biotechnologie2019-04-26Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Global Regulatory Affairs Manager

Responsibilities

• Provided regulatory assessment/input for various Manufacturing Change Controls, Annual PQRs, Artwork Changes, Risk Minimization tools and PSUR/PBRERs

• Executed multiple and complex global regulatory submissions and interactions with Health Authorities to support clinical trials, product registration and post marketing commitments.

• Defined Worldwide Regulatory Requirements for changes including: clinical (extension of indication) & CMC strategies (FP and API manufacturing site changes, sterilization process change), prepared variations and supplements, answers to authorities' requests.

• Liaised with necessary cross-functional areas, partners, vendors and distributors to proactively and collaboratively resolve regulatory issues.

• Created/maintained regulatory SOPs, assisted with internal self-audits and inspections.

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La référence de cette offre est JN -042019-295437 - HAID

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