Director, Regulatory Affairs CMC

Role Summary

Director, Regulatory Affairs CMC. Lead the preparation of CMC Regulatory documents from pre-IND to marketing authorization submissions in multiple therapeutic areas, molecules, and regions. This position will lead direct reports in the CMC regulatory team, keep up to date on evolving regulations, and lead regulatory intelligence activities. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities

• Effectively maintain, and motivate a high-performing regulatory CMC team, including developing, coaching, and mentoring diverse, talented, and driven staff
• Lead regulatory - CMC intelligence activities
• Lead regulatory CMC activities for assigned projects consistent with global regulatory requirements , and company policies and procedures
• Provide Regulatory CMC guidance to internal teams and lead cross-functional teams to plan and prepare briefing packages, and CMC sections for INDs, and equivalent IMPD sections for CTAs, NDAs/MAAs and other global submissions
• Assess the regulatory impact of proposed manufacturing process changes
• Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports
• Lead interactions with regulatory agencies for assigned programs
• Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines, and communicate changes in regulatory information to cross-functional teams

Qualifications

• Preferred: Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
• Preferred: Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with Global regulatory agencies
• Preferred: Excellent verbal and written communication skills

Education

• Preferred: Bachelor's or advanced degree in a scientific discipline, with 10+ years of experience working in Regulatory Affairs in the biopharmaceutical industry
• Preferred: Experienced in building, developing, and managing high functioning teams
• Preferred: Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/MAA
• Preferred: Direct experience with regulatory submissions to PMDA is desirable
• Preferred: Experience with small molecules is preferred
• Preferred: Experience in successfully leading assigned activities within cross-functional teams