Alpha Clinical Development is seeking a highly skilled Associate Director / Director of Regulatory Affairs for a remote role based on the Pacific Side, USA. The ideal candidate will have extensive experience in FDA submissions (BLA, NDA, and other regulatory filings). Oncology experience is highly desirable.
Key Responsibilities
- Lead regulatory strategy and submissions for FDA applications (BLA, NDA, etc.).
- Interact effectively with FDA and other health authorities.
- Ensure compliance with regulatory requirements and industry best practices.
- Provide strategic guidance for regulatory submissions and approvals.
- Collaborate with cross-functional teams to support clinical and commercial development.
Qualifications
| Requirement | Details |
|---|---|
| Education | Master’s degree in Life Sciences or a related field (PhD or advanced degree preferred) |
| Experience | 8-12+ years in regulatory affairs with strong FDA submission experience |
| Specialization | Oncology experience is highly desirable |
| Skills | Strong knowledge of regulatory guidelines, effective communication with FDA, leadership skills |
Why Join Us?
- Remote Flexibility: Work from anywhere within the Pacific Side, USA.
- Career Growth: Opportunity to lead regulatory projects and interact with key industry stakeholders.
- Impactful Work: Play a crucial role in regulatory strategy and FDA approvals.
How to Apply
If you meet the qualifications and are excited about this opportunity, send your resume to:
Join Alpha Clinical Development and contribute to innovative regulatory strategies in the pharmaceutical industry!
