D.C. Metro Area, United Kingdom
$180,000 - $220,000
3 months ago
- Lead the strategy for ongoing and upcoming regulatory submissions (IND, CTAs and NDAs/BLAs) with products currently going through promising clinical trials
- Act as point of contact for Regulatory Agencies between US and global teams;
- Develop, review and complete submission documents in collaboration with other functional disciplines.
- Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders.
- Participate in the development and implementation of short- and long-term Regulatory plans for key projects;
- Guide Nonclinical, CMC and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs;
- Lead preparations and delivery of FDA communications with Clinical Development Teams
- Minimum of a Bachelor’s Degree in an applied science field. Ph.D degree is highly preferred.
- 10+ years' Regulatory Affairs experience in drug development and/or registration activities is a must.
- Proven track record of successful strategy leadership and management within a regulatory function.