Associate Director, RA CMC

Responsibilities:
- Prepare CMC regulatory product strategies and manage submissions (new applications, amendments, renewals annual reports, supplements, variations, and responses to regulatory information).
- Analyze and interpret information impacting regulatory decisions; seek technical support as needed.
- Review and revise submissions to present data and strategy effectively to regulatory agencies.
- Develop strategies for CMC agency meetings; manage preparation and pre-meeting submission content; serve as point of contact for meetings.
- 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/regulations/guidance and provide organizational analysis.
- Develop, implement, and document RA CMC policies and procedures; lead internal initiatives.
- Represent CMC regulatory affairs on cross-functional 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 experience: 8 years pharmaceutical experience with at least 3 years of demonstrated leadership.
- Preferred experience: 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 environments; strong oral and written communication skills.

Benefits (if applicable): paid time off, medical/dental/vision insurance, and 401(k); eligible for long-term incentive programs.