This growing biotech company is focused on transforming the lives of patients with severe genetic diseases and cancers. They are seeking a Regulatory CMC Sr. Manager or Associate Director to plan, write, and coordinate Regulatory CMC sections of INDS, CTAs and BLAs for CAR-T cell therapy programs. You will collaborate closely with regulatory, manufacturing, and Quality teams, along with contract manufacturing organizations, and global health authorities. This company offers a fun, collaborative culture, a generous PTO package, and excellent benefits. Now is an exciting time to join this fast-paced, energetic, and rapidly growing company!
- Contribute to global Regulatory CMC strategies for the development of CAR-T oncology programs.
- Manage and implement planning, preparation and submission of high-quality CMC applications in the US and EU.
- Ensure that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures, pediatric investigation plans, and MAAs or BLAs are complete, well written, and meet all relevant requirements.
- Prepare and submit responses to health authorities regarding CMC questions.
- Participate as needed in interactions with regulatory agencies during GMP and pre-approval inspections.
- Participate in negotiations with regulatory agencies to resolve CMC issues.
- Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
- Partner with internal teams to ensure achievement of submission deadlines and obtain timely approvals of CMC‑related applications.
- Participate in regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to project teams.
Knowledge and Skills:
- Bachelor’s degree in life sciences (biochemistry, chemistry, biology or related pharmaceutical fields). Advanced degree, such as MS or PhD is desirable.
- At least 5+ years’ experience in Regulatory CMC for prescription therapeutics.
- Must have Regulatory CMC experience with biologics. Experience with cell or gene therapy a plus.
- Understanding of relevant drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines.
- Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines.
- Familiarity with CMC operations, including Quality and Manufacturing technical strategy.
- Effective problem solving and excellent interpersonal skills.
- Must have the ability to prioritize multiple tasks and work under time pressure.
- Ability to work both independently or collaboratively in a team structure and thrive in a fast-paced environment.
- Superb organizational and communication skills, both written and oral skills, and “do-what-it-takes” attitude.
- Independently motivated, detail-oriented and good problem-solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.