Regulatory Affairs Specialist
3 giorni fa
Job Summary
- Represent the EU region for regulatory sciences in early-stage oncology portfolio management, collaborating with stakeholders to ensure timely submissions and approvals.
- Contribute regional strategic expertise to the Global Regulatory Strategic Team (GRST) and lead EU regulatory strategies for assigned projects/products.
- Ensure optimal regulatory interactions with Health Authorities, focusing on the designated early-stage oncology portfolio within the EU.
Key Responsibilities
- Accountable for EU contributions to Global Regulatory Strategies and implementation plans, including core labels, risk registers, and submission activities.
- Develop and implement regulatory strategies, ensuring compliance with EU regulations and guidelines, and managing risks associated with emerging technical data.
- Collaborate with project teams to provide required regulatory contributions (CTA, etc.) and promote business compliance with Regulatory standards.
- Develop and maintain constructive working relationships with Health Authority contacts in the EU region and engage in activities to influence the EU regulatory environment.
Organizational Relationships
- Reports to the Early Phase Oncology EU Lead and works closely with GRS colleagues, project teams, and external contacts in Regulatory Agencies within the EU region.
- Ensures alignment with GRL and the Early Phase Oncology Global Head, promoting a collaborative and cohesive approach to regulatory affairs.
Qualifications and Skills
- Scientific degree (higher degree preferred but not essential); proven experience in managing national and EU regulatory processes and registration aspects of the drug development process.
- Strong communication, negotiation, and presentation skills, with the ability to communicate complex information effectively to various audiences, including senior management.
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