Regulatory Affairs
Regulatory Affairs Documentation Specialist
Opportunity summary
Employment type: Full time. Requisition: JR376. Start: 2026-09-04. Country: [object Object].
Does it excite you to keep regulatory submissions on track for one of the industry's most closely watched obesity programs, and do you have a talent for turning cross-functional input into submission-ready documentation? If this sounds like you, and you are ready to take on a broad area of responsibilities across our clinical pipeline, then you could be our new colleague.
Your new position As our new Regulatory Documentation Specialist, you will support the petrelintide projects, driving the operational delivery of CTA/IND/NDA/MAA/PIP and meeting package submissions. You will be the operational backbone of our submission management process, working closely with RA and cross-functional colleagues, and external stakeholders to ensure high-quality, submission-ready documents.
This is a role for someone who thrives on structure, detail, and keeping regulatory activities on track.
We offer exciting responsibilities
- Drive the planning, coordination and execution of CTA/IND/NDA/MAA/PIP/PSP meeting package submissions in line with regulatory strategy, ensuring timely delivery1 …
This is a shortened extract from the public vacancy. Follow the original posting for the complete and authoritative description.