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Senior regulatory affairs manager

Woolley (BA1 8)
Randstad
Regulatory affairs manager
Posted: 6 June
Offer description

Are you an experienced Senior Regulatory Affairs Manager? Do you have experience in the International Growth Markets? If so, we would love to hear from you! The successful candidate will become a member of our clients regulatory project team representing Middle East Africa, Turkey, CIS & Russia and Central Eastern European Markets in the International Growth Markets team with accountability for 1-3 products progressing through NDA planning, filing and approval. This is a contract position, offered initially for 6 months, working 37.5 hours per week. (Preferably 2 days a week in the office / Inside IR35). Responsibilities: Provides regulatory support to IGM Cluster Head for new regulatory filings with specific individual accountability for development of NDA submission and major line extension including labelling strategies and execution Manages the communication, development and implementation of NDA and major line extension strategy assigned product(s) in Middle East Africa, Turkey, CIS & Russia and Central Eastern European Markets Working closely with global, regional and in-country regulatory teams Responsible for development and delivery of regulatory strategy for assigned products Working closely with partner and affiliate counterparts, supply chain, PV, commercial and medical colleagues where required to determine optimal NDA filing and launch strategy Ensuring delivery of strategy to the timelines agreed working in partner...

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