21 days ago
Vice President, Regulatory Affairs (Oncology)
- Lead Global Regulatory Affairs and build out the Regulatory team
- Ensures compliance with US and Global regulatory agencies and requirements
- Build the regulatory strategy across the company’s product portfolio
- Provide expertise and leadership in the development of regulatory approvals worldwise
- Strategically assess which products in the development pipeline will be able to move through the regulatory process successfully
- Lead interactions with global regulatory authorities and build relationships with regulatory agencies
- Develop timelines and coordinate the activities of all departments towards achieving high-quality and on-time submissions.
- Manage changes in product labeling.
- Manage the provision of regulatory information to both internal and external customers through commercial communication.
- 20+ years’ progressive related experience in drug development with at least 15 years in regulatory affairs.
- Regulatory Affairs Professional Society (RAPS) certification preferred.
- Graduate degree is preferred, but a bachelor’s degree is acceptable with additional experience.
- Prior experience as a Director or above
- Established relationships with regulatory agencies are desirable.
- Excellent knowledge of the USA/EU regulatory pharmaceutical framework. Proven experience of achieving regulatory approvals in the USA and EU.
- A commercial focus in the application of regulatory requirements.