Director-Senior Director, Global Regulatory Affairs
New Jersey - United States
Seeking an experienced Director-Senior Director of Global Regulatory Affairs to join a small but growing, late-clinical stage, oncology pharmaceutical group in New Jersey. Looking for skilled Regulatory Affairs professionals with a proven and successful track record within the Oncology therapeutic area. This Director will serve as the departments subject matter expert for all global Clinical Studies and global submissions (i.e.: eCTD for IND and NDA, MAA, etc.). Seeking candidates with prior hands-on experience managing and working with these studies and submissions and have had direct interactions with global health authorities. Seeking confident and experience regulatory candidates to lead development, as well as, plan, execute, interpret and present all regulatory strategy while working collaboratively and cross-functionally with the team.
- Strong knowledge of FDA, EMA, ICH and GxP strategies to ensure compliance of requirements from healthy authorities for clinical studies and submission.
- Address and resolve regulatory issues arising in pre-clinical, clinical and commercial development programs.
- Lead end of phase meetings and clinical regulatory strategy for oncology programs.
- Direct interactions with global regulatory authorities; lead meetings and support clinical and commercial regulatory activities.
- Strong knowledge of international regulatory guidelines.
- Experience with clinical and commercial strategies for small molecules in oncology to support the growing portfolios.
- Master's degree in Regulatory Affairs or Biology or life sciences with a 10+ years of relevant pharmaceutical/biotech industry experience within regulatory affairs; Advanced degree (PharmD preferred) and RAPS certification is highly favored.
- Global experience (i.e.: EMA, PMDA, Health Canada, etc.) is required.
- Oncology and small molecule experience are required; cancer metabolism is highly preferred.
- Extensive experience in strategic planning, program design, project and budget management.
- Experience with Clinical Regulatory oversite of global trials.
- Key skills: Leadership, management, communication, negotiation and presentation skills.
If interested in learning more, please contact me at firstname.lastname@example.org or (646) 430-1191 for more information.