Associate Director, RA CMC

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships across Regulatory Affairs, Operations, and Research & Development (R&D). Represents CMC on teams (product development, Global Regulatory Product Teams, Operations brand teams) to negotiate, influence, and provide strategic advice. Serves as liaison with regulatory agencies (e.g., FDA) regarding CMC matters.

Responsibilities:
- Prepare CMC regulatory product strategies; manage submissions (new applications, amendments, renewals annual reports, supplements/variations) and respond to regulatory information.
- Analyze/interpret information impacting regulatory decisions; seek technical support as needed.
- Review and revise submissions to present data/strategy effectively.
- Develop strategies for CMC agency meetings; manage pre-meeting submissions; serve as point of contact.
- Manage products and change control; analyze and approve manufacturing change requests.
- Represent CMC regulatory affairs on assigned projects; negotiate and influence team members to maximize first pass approval.
- Stay abreast of regulatory procedures and changes; analyze legislation/regulation/guidance.
- Develop/implement/document RA CMC policies and procedures; lead internal initiatives.
- Represent CMC regulatory affairs in cross-functional initiatives to drive efficiencies.
- Train, develop, and mentor individuals (may include supervisory responsibilities).

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

Benefits: Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.