Sr Reg Affairs Manager Eu/cta Outside Ir35
6 days ago
**PE Global is currently recruiting for a Sr Reg Affairs Manager (EU/CTA) OUTSIDE IR35forour leading multi-national Biotech client in London (hybrid role).**
This position focuses on providing regulatory affairs support to recently approved product for development lifecycle activities (new indications) as well as support to ongoing early development Phase 1/2 development programs. This individual will help provideboth strategic and operational support to development and implement the strategy for both the development programs in Europe.
**Responsibilities**:
- Ensure the development and articulate of the strategy and appropraite planning, preparation, and submission of Health Authority submissions as well as Health Authority Interactions in Europe and potential for global interactions.
- Provision of strategic insight to the project team regarding product development in Europe and the impact of guidance and policy change as it might impact the global strategy.
- Communicating with regulatory consultants and CROs regarding product development plans
- Manage interactions and relationship with Health Authorities in Europe or other regulatory authorities as assigned
**Requirements**:
- 5 years’ experience in doing regulatory submissions, Health Authority meetings, PIPs and ODDs.
- Has worked on early development programshase 1 and 2.
- Has lead internal senior level meetings articulating and answering questions regarding the development and regulatory strategy.
- Ideally direct experience of leading internal development and leading meeting regarding requirements and submissions for PIP, ODD and Scientific Advice in Europe.
- Confident working with internal Nonclinical and clinical Subject matter experts as well as communicating to Senior Management.
Please click the link below to apply, call Amparo on + or alternatively send an up to date CV
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