Senior Manager, Regulatory Affairs CMC, New Markets & Life Cycle Management

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Senior Manager, Regulatory Affairs CMC, New Markets & Life Cycle Management

Hørsholm

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Y-mAbs is now looking for a Regulatory Affairs CMC senior manager in a newly established position in Global Regulatory Affairs. You will become an important part of managing regulatory submissions and approvals in new markets and establishing LCM. You will report to the LCM Lead of Global Regulatory Affairs.

Key responsibilities:

Handle new markets and LCM CMC activities
Cover regulatory CMC across products from MAA/BLA stage and into LCM and new markets, including providing input to and reviewing regulatory CMC documents
Responsible for regulatory maintenance of marketed products globally (major / minor changes, annual reporting etc.)