Director GRA Solid Tumors (gn)
For an international, EU based pharmaceutical company with a broad product portfolio, we are currently looking for a Director Global Regulatory Affairs to head a team within the oncology division and act as a Regulatory Lead.
- Global company with international setting
- Very strong oncology pipeline with ongoing filings and launches
- Attractive and flexible salary package according to local requirements, including remote work
- Reporting line to Head, Global Regulatory Affairs Oncology within the Corporate Direction Regulatory Activities and Market Access.
- As part of the Global Regulatory Affairs Oncology team, directly manage and provide leadership and mentorship to a team of regulatory representatives responsible for the assigned products.
- As active member, participate in multi-disciplinary teams in order to define the development and regulatory strategies of early and late stage development programs. Identify and communicate potential risks associated with different strategy scenarios.
- Contribute to the development of the Target Product Profile in collaboration with other R&D functions.
- Represent and coordinate regulatory information as a team member, covering clinical, labelling, protocols, reports, presentations, and other documents.
- Coordinate the preparation, review and submission submissions as required, including marketing applications. Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions.
- Manage submission plans and timelines to ensure approvals and development objectives are timely met.
- Review and analyse competitors’ information, recent product approvals local public Advisory Committee proceedings and global Agencies’ guidelines, to support the development of strong regulatory strategies.
- Regulatory review of potential in-licensing opportunities and participation in regulatory due diligence activities.
- Document regulatory contacts with Health Authorities.
- Manage regulatory data and information within systems.
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