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 management in c...