Senior Manager, Regulatory Affairs Strategy
- Regulatory Affairs
Senior Regulatory Affairs Manager
Job Ref: JO-1807-412553
Regulatory Professionals are collaborating closely with a large pharmaceutical company based in Hertfordshire who are looking for a couple of Senior Managers to join their therapeutic teams. The successful candidate will have extensive life-cycle management from early phase development through to post approval submissions. Furthermore, candidates who have been actively involved from product registration through to product launch of at least one product are highly desirable.
- Lead the preparation and submittal of Clinical Trial Applications (CTA), Paediatric Investigation Plans (PIP) and Orphan Drug Designations (ODD).
- Involvement in post approval work for Centralised products.
- Close liaison with US counterparts, commercial teams and external partner management
- Authoring and collation of Marketing Authorisation dossiers (MAAs) for global health authority submission.
- Ensuring that Regulatory documentation meets relevant Regulatory requirements and company quality standards.
If you have up to date experience of lifecycle management including initial MAA and post approval submission knowledge then get in touch by sending your CV to firstname.lastname@example.org or call 0118 9522 797 for further details.