Associate Director/Director Regulatory CMC
My client aspires to do create solutions to patients world-wide who suffer from rare orphan diseases. With cutting edge programs within deep, novel technology platform, they are one of the premier clinical stage drug development companies world-wide. They are seeking an Associate Director (or) Director of Regulatory CMC to be one of the leaders for their upcoming MAA filing. Additionally, they have another MAA filing scheduled in the next three years with seven other programs in development. They offer a professional yet casual work environment, where no matter what your role is within the company, your ideas are heard. The ideal individual must be able to identify solutions to problems which have not yet happened, be positive, and have a supportive mentoring management style.
Responsibilities:
- Manage CMC Regulatory activities and timelines
- Manage and implement planning, preparation and submission of high-quality CMC-related applications in the US, EU and Australasia
- Oversee planning, preparation and submission of high-quality CMC-related applications globally
- 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
- Participate in discussions with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally
Knowledge and Skills:
- Minimum BA/BS degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; higher degree preferred
- Minimum 5 years of relevant biopharmaceutical industry experience, with at least 3 years’ experience in CMC-focused Regulatory Affairs preferably for biologics
- Must have experience working in biologics
- Must have FDA filing experience
- Late state CMC section filing experience a must
- Orphan drug experience a plus
- Experience working in a smaller company environment a plus
- Detail oriented; science-based reasoning skills