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 Executive 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 and a strong pipeline, this an exciting time to join this growing organization!
Responsibilities:
- Develop and implement Regulatory CMC strategies and plans for small molecule drug 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 of 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.
- Strong interpersonal skills
- Must have excellent communication skills (verbal and written).
- 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.
*Note: This company prefers candidates in the NY/NJ/CT/PA/MA area who can visit the office regularly