Regulatory Affairs Specialist, Oncology Therapy Area, Research & Development
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About this role
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.
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 collaboration with Regulatory Operations or external vendors. Perform quality control checks to ensure submission documents are complete, accurate, and compliant.
- Regulatory Strategy Support: Execute regulatory strategy tasks as defined by senior team members (Regional Regulatory Leads/Global Regulatory Leads). Gather regulatory intelligence to support development decisions. Track regulatory commitments, key milestones, and health authority feedback for ongoing projects.
- Cross-Functional Collaboration: Collaborate closely with Clinical Development, Clinical Operations, Nonclinical Development, Medical Writing, CMC, and external partners to gather necessary data and documents for submissions. Assist in coordinating internal review cycles, consolidating feedback, and ensuring timely approvals of documents. Actively participate in relevant meetings and document key decisions and action items.
- Health Authority Interactions: Assist in preparing for health authority meetings and correspondence, primarily with Europ