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You will take charge of leading regulatory CMC strategy and execution for one or more transformative medicine programs. This pivotal role involves developing and implementing...
We are looking for an experienced Regulatory Affairs CMC (RA CMC) Associate Director, who will be responsible for RA CMC strategy support to second line regulatory approvals, as...
Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a...
Manage, prepare, finalise CMC sections of EU IMPD/MAA and rest of world equivalent documents. Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior...
Lead design of preclinical and/or clinical studies needed to support health benefit claims. Author, update and maintain relevant scientific documentation. Work closely with Product...
As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to...
Management of cases with pharmacovigilance and materiovigilance departments. Regular training of Sales resources (place of the radiopharmaceutical in the strategy tree of...
Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled...
Responsible for providing strategic regulatory guidance on the global pediatric development in alignment with and within the overall development of a product; Lead multiple...