Director, Regulatory Affairs CMC
Reporting to the Executive Director of Regulatory Affairs, the Director of Regulatory Affairs CMC is responsible for the operational implementation of global regulatory strategies regarding the chemistry, manufacturing and controls (CMC) of approved drug products and those in development.
PRIMARY JOB FUNCTIONS
- Collaborate with the Executive Management of Regulatory Affairs to develop regulatory strategies regarding CMC for investigational drug products and commercially approved products
- Advise technical teams associated with the development and manufacturing of drug products on regulatory requirements to successfully implement regulatory strategies.
- Maintain the CMC sections of regulatory submissions, including INDs, CTAs, NDAs, MAA
- Author and/or manage technical writers for CMC regulatory documents
- Review all protocols and reports used as source documents CMC documents for regulatory submissions
- Interact with regulatory authorities as appropriate in the capacity of the CMC regulatory expert. Respond to Regulatory Authority requests for information.
- Establish accurate plans and timelines for CMC sections of regulatory submissions
- Work closely with Regulatory Operations to ensure CMC documents are of high quality and meet the requirements for inclusion in electronic or paper submissions as appropriate
- As required, work with Quality Assurance to ensure CMC regulatory compliance during drug product development through approval, including but not limited to the development of operating procedures, maintaining training currency, and review of product complaints and of change controls for regulatory submission requirements.
- Monitor and review new regulations and guidance documents concerning CMC and advise company management and staff of impact on the company’s development candidates and approved drug products.
ESSENTIAL QUALIFICATIONS & SKILLS