Senior Manager, Regulatory Affairs CMC
Salary: ($150,000-$170,000)
Remote Role - CA
This pioneering biotech company has captivated the industry with its revolutionary advancements in Immunotherapy and Oncology. Through their groundbreaking research, they hold immense potential to transform disease treatment. This organization, which currently has 4 Oncology products in Phase 3, is currently seeking a Senior Manager (CMC) to head up their Regulatory Affairs team in the Biologics division.
Responsibilities:
- Proactively oversee the Chemistry, Manufacturing & Controls (CMC) aspects of biologic products throughout their development stages, collaborating with various departments
- Write and evaluate CMC sections of applications and revisions for submission
- Coordinate the revision of regulatory sections and lead meetings to resolve discrepancies
- Contribute to and evaluate the CMC content of original INDs, annual reports, DSURs, etc.
- Monitor and report on external regulatory CMC guidance and changes in pharmacopoeia
An ideal candidate for this role will have:
- Bachelor's Degree within Life Sciences
- Experience in CMC Biologics (at least 5 years)
- Strong communication skills and able to meet deadlines
- Experience using regulatory managements systems
The firm offers competitive compensation packages and values their employees through:
- Health and life insurance
- 401(k) or Roth 401(k) match
- Stock
- 3 weeks PTO
- Fitness allowance
If you're interested in this role, email jack.compton@epmscientific.com to apply now!
