Darum lohnt es sich
You’ll have a direct impact on the global regulatory strategy of a promising oncology pipeline while working alongside internationally recognised experts in drug development. /p h3Interested? /h3 pWe’d love to tell you more. /p /p ph3Director, Regulatory Affairs CMC Europe /h3 pReady to lead the CMC regulatory strategy for novel small-molecule therapies in oncology? /p pWe’re partnering with an innovative biotechnology company that is advancing a portfolio of next-generation targeted oncology therapies.
As the pipeline progresses towards global registrations, we’re looking for an experienced Director, Regulatory Affairs CMC – Europe to shape global CMC strategy and play a key role in bringing breakthrough medicines to patients. /p h3Your Responsibilities /h3 ul liLead the global CMC regulatory strategy for innovative small-molecule development programmes. /li liDrive CMC activities across clinical development, registration and lifecycle management. /li liDevelop and oversee global CMC submission strategies, including Module 3. /li liLead interactions with global Health Authorities, including the FDA and EMA. /li liPartner closely with Technical Development, Quality, Manufacturing and Supply Chain to ensure successful global submissions. /li liAssess regulatory risks and provide strategic guidance throughout product development. /li /ul h3What We’re Looking For /h3 ul liSignificant experience in bRegulatory Affairs CMC /b within the pharmaceutical or biotechnology industry. /li liStrong background in bsmall molecules /b, bideally New Chemical Entities (NCEs) /b. /li liExperience developing and executing bglobal CMC regulatory strategies /b from clinical development through registration and lifecycle management. /li liStrong knowledge of bModule 3 /b, global CMC submissions and Health Authority interactions. /li libOncology experience is highly desirable. /b /li liA collaborative leader who thrives in a fast-paced, science-driven biotech environment. /li /ul h3Why Join? /h3 pThis is an opportunity to join a highly innovative biotechnology company at an exciting stage of growth.
