Regulatory CMC Sr. Manager or Associate Director

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 and gene 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! 

Responsibilities:

  • Contribute to global Regulatory CMC strategies for the development of gene therapy and 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.

 

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