Regulatory Affairs Specialist, Oncology Therapy Area, Research & Development

Job Description

Orion Pharma’s Research and Development is looking for a Regulatory Affairs Specialist to support EU and global regulatory activities for our oncology and pain development-stage pharmaceutical programs.

In this role you will work under the guidance of senior regulatory professionals to prepare and manage regulatory submissions and contribute to cross-functional project teams within R&D. This is an excellent opportunity for a junior-to-mid level regulatory professional to deepen hands‑on experience in clinical development and regulatory submissions. You will be part of a global team with colleagues based in the US, UK, and Finland.

Key Responsibilities

• Regulatory Submissions: support the preparation, compilation, and maintenance of regulatory submission packages (e.g. Clinical Trial Applications (CTAs) via CTIS, INDs, amendments, annual reports, briefing documents). Coordinate eCTD publishing and document lifecycle manageme...