Senior Regulatory Strategist – Oncology
We are delighted to offer this full-time role with a major biopharma based in Switzerland.
Working remotely in a team of three G&L Regulatory Consultants, this role has an immediate start for an initial period of 12 months.
This role is assigned to the company’s oncology portfolio and requires EU specific MAA strategy experience, including Orphan products, Scientific Advice meetings, HA interactions, supporting EU MAAs.
Duties include, but are not limited to:
- Responsibility for implementing regulatory strategy and managing operational activities for assigned regions.
- Providing input into global regulatory strategy and contributing to Regulatory functional plans, including identification of gaps or risks in the global strategic plan for assigned regions.
- Determining requirements and setting objectives for Health Authority (HA) interactions.
- Facilitating preparation and finalisation of briefing books.
- Developing and implementing plans for timely response to HA requests and coordinating responses.
- Leading rehearsals for HA meetings.
- Leading HA meetings independently where needed.
- Serving as the local HA liaison depending on location (e.g., FDA or EMA).
- Driving coordination, planning, and submission of dossiers in assigned regions worldwide.
- Reviewing global dossier summary documents.
- Reviewing, approving and submitting Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
Freelance contract opportunity
Full time (37.5 hours per week)
12 month period
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