Associate Director, RA CMC

Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

Responsibilities:
- Prepare CMC regulatory product strategies; prepare and manage regulatory submissions (new applications, amendments, renewals annual reports, supplements/variations, and responses to regulatory information).
- Analyze and interpret information impacting regulatory decisions; seek expert/technical support as needed.
- Review and revise regulatory submissions to effectively present data and strategy to regulatory agencies.
- Develop and manage strategies for CMC agency meetings; manage pre-meeting submission content and serve as point of contact.
- Manage products and change control; analyze and approve manufacturing change requests.
- Represent CMC Regulatory Affairs on product development, Global Regulatory Product Teams, and Operations brand teams; negotiate and influence to maximize first-pass approval.
- Stay current on regulatory procedures and changes; analyze legislation, regulation, and guidance.
- Develop, implement, and document RA CMC policies and procedures; lead internal RA CMC initiatives.
- Represent CMC on cross-functional project initiatives to drive efficiencies.
- Train, develop, and mentor individuals (may include supervisory responsibilities).

Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field.
- Preferred: relevant advanced degree; certification a plus.
- Required: 8 years pharmaceutical experience with at least 3 years demonstrated leadership.
- Preferred: 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery/R&D/Manufacturing.
- Experience developing and implementing global regulatory strategies; experience working with Health Authority.
- Experience in complex/matrix environment; strong oral and written communication skills.