This growing biotech company is focused on transforming the lives of patients with severe genetic and rare diseases. They are seeking a Regulatory CMC Director (or Associate Director) to lead regulatory CMC strategy and execution for multiple gene therapy programs in development. You will oversee the preparation and submission of high-quality CMC sections of INDs, CTAs, BLAs and MAAs while managing a small team. 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!
- Provide regulatory CMC strategic leadership to support development of multiple innovative gene therapy products for the treatment of severe genetic diseases.
- Manage and implement planning, preparation and submission of high-quality CMC applications in the US, EU, Japan, and other countries.
- Ensure that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures and pediatric investigation plans, and MAAs or BLAs are complete, well written, and meet all relevant requirements.
- Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections.
- Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals.
- Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
- Partner and work very closely with Pharmaceutical Science, Quality, Nonclinical, Clinical and Regulatory project leads to ensure achievement of submission deadlines and obtain timely approvals of CMC‑related applications.
Knowledge and Skills:
- Master degree in life sciences (biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering). Higher degree, such as a PhD or Pharm D is desirable.
- At least 8+ years’ experience in Regulatory CMC for prescription therapeutics.
- Must have Regulatory CMC experience with biologics. Experience with cell or gene therapy a plus.
- Direct interactions with regulatory health authorities and experience with BLA/MAA filings.
- Experience in post-approval dossier life cycle management and direct interactions supporting health authority GMP inspections desirable.
- Excellent written and communication skills, strong technical knowledge, including CMC‑regulatory writing.
- Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc
- Detail oriented; science-based reasoning skills; ability to execute and follow-through to completion.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Independently motivated and solution oriented.