Associate Director, RA CMC

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. 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 within Regulatory Affairs, Operations and R&D. Represents CMC on product development, Global Regulatory Product Teams and 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 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 submissions to present data and strategy effectively.
- Develop strategies for agency meetings; manage meeting preparation and pre-meeting submissions; serve as point of contact.
- Manage products/change control; analyze and approve manufacturing change requests.
- Represent CMC regulatory affairs on cross-functional teams; negotiate and influence to maximize first pass approval.
- Stay current on regulatory procedures and changes; analyze legislation/regulation/guidance.
- Develop, implement, and document RA department policies/procedures; lead RA CMC initiatives.
- Represent CMC on project initiatives to drive efficiencies.
- Train, develop, mentor individuals; may include supervisory responsibilities.

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

Benefits:
- Comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for long-term incentive programs.