This growing pharmaceutical company is developing and commercializing transformative medicines in neuroscience and immuno-oncology utilizing artificial intelligence approaches. They are seeking a Regulatory CMC Senior Director or Director who can develop and lead CMC Regulatory strategies for their programs in development and approved products. This company offers a collaborative company culture and the ability to work remotely (with some regular visits to their office.) With their first program just approved by FDA in early April, this an exciting time to join this growing organization!
Responsibilities:
- Develop and implement Regulatory CMC strategies and plans for programs in development and approved products.
- Provide CMC regulatory direction and coordination in the preparation of regulatory submissions consistent with regulatory requirements.
- Define and implement global regulatory CMC strategies, ensuring that all regulatory CMC requirements/ commitments are met with respect to regulatory submissions for INDs, IMPDs, MAAs, NDAs and other regional submissions.
- Provide expert regulatory CMC input to cross-functional Project Teams for product development and submissions, and drive regulatory milestones.
- Regulatory CMC lead for the review of documentation including those at CROs and CMOs.
- Responsible for registrational batch manufacture and test plan and Validation strategy.
- Review and approve internal documentation supporting product development (e.g. clinical protocols, labeling requirements for clinical studies, review of batch documentation, statistical analysis, annual report review, vendor qualification)
- Manage a team of Regulatory CMC employees and/or contractors.
- Provide regulatory input into project teams as required in problem solving/issue resolution, documentation, etc.
- Lead Preapproval inspection meetings including preparation, documentation and follow up actions.
- Act as primary CMC contact for inquiries from regulatory agencies. Participate and lead communication and negotiations with Regulatory Agencies. Support cross-functional teams in Health Authority meetings.
- Monitor and keep current on new and changes to regulatory requirements and procedures.
- Ensure on-time submission activities related to regulatory file maintenance, i.e., IND/CTA, information amendments, SAE reports, etc.
- Coordinate with consultants and CROs assisting with submission activities, including preparing electronic submission documents.
- Ensure maintenance of regulatory project logs/databases, tracking the submission status of reports and other regulatory activities.
Qualifications:
- Master of Science degree required. Advanced degree such as PharmD or PhD preferred.
- Minimum of 8 years direct CMC Regulatory Affairs experience in pharma or biotech.
- Must have experience managing CMC submissions for marketing authorization applications (e.g. NDA, NDS and MAA) in eCTD format.
- Experience in CMC submission writing and review essential.
- Experience in Orphan Designated disease development a plus.
- Must have experience in direct interaction with Regulatory Agencies
- Excellent organizational, planning, follow-up skills.
- Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
- Background in analytical chemistry and experience defining regulatory-quality processes.
- Must have excellent communication skills (verbal and written) and strong interpersonal skills.
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Able to work effectively with CRO, CDMO and CMO partners.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.
- A bias towards action combined with high ethical standards is essential.
- Initiative, combined with a high energy level is critical to success.
- Must successfully exhibit corporate values of: Respect, Passion Integrity, Collaboration, and Accountability.
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
*Although this is a remote role, our client prefers candidates in the Eastern Time Zone for this position