Director, Regulatory Affairs (CMC) – NC Pharma/Remote (US – based)
Our client, a rapidly-expanding biopharma company headquartered in Research Triangle Park, NC, is actively recruiting for a highly skilled Regulatory Affairs leader to develop and drive all Regulatory CMC (Chemistry Manufacturing and Controls) efforts in support of clinical and commercial stage drug development.
This is a remote opportunity that can be based anywhere in the US. Company will pay top dollar to attract and retain an excellent candidate.
Key Things to Note:
- This company develops small molecule products in oncology as well as other severe disease states. It has commercial products and is developing multiple compounds. Seek candidate with both commercial and clinical exposure.
- It is a global company. This Director will lead CMC strategy efforts as well as develop and drive global CMC regulatory strategy in collaboration with other local and global functions/departments. Seek candidate accustomed to a global setting and a highly collaborative work dynamic.
- Company uses third party vendors for key functions. Experience overseeing external parties is required.
- This Director will be responsible for the preparation and review of responses to health authorities. Experience interacting with Regulatory authorities will be important.
- This is an emerging business environment in which policies and protocols are still being developed and enhanced. Experience developing robust regulatory timelines and action plans for technical and strategic CMC activities will be needed.
- Lead robust CMC strategy efforts and develop and drive global regulatory strategy for CMC sections in collaboration with other local and global regulatory functions, Product Supply, CMC and biotech development functions as well as Clinical and Non-Clinical Development
- Lead local and/or global health authority communications concerning CMC development
- Serve as representative for RA CMC in development teams and global regulatory teams
- Be responsible for the final CMC content of health authority submissions and replies to health authority questions
- Ensure early identification of major regulatory issues and conduct appropriate management escalation as required
- Assume responsibility for conducting due-diligence activities relevant to regulatory CMC aspects, in support of ongoing product acquisitions
- Assist with efforts to ensure timely and adequate surveillance of both the local and global regulatory landscapes relative to CMC product development
- Conduct in-depth and thorough review of technical documentation to support clinical and commercial stage drug development
Requirements include a Bachelor’s degree in a scientific field (advanced degree, PharmD, PhD, MS, preferred) and 10+ years of increasingly responsible roles in Regulatory Affairs, with particular expertise in CMC strategies.
Other priorities include:
- Substantial knowledge and understanding of regulatory requirements globally
- Demonstrated ability to develop regulatory timelines and action plans for technical and strategic CMC activities; experience in an emerging pharma setting preferred
- Exceptional project leadership skills including demonstrated ability to manage complex timelines in a fast-paced team environment
- Ability to make decisions, think critically, solve problems and respond proactively
- Small molecule expertise expected
This position has great potential. We seek a natural point person and one who can have great impact. Longevity, upward mobility and record of impact in previous positions will all be important.