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 (INDs/CTAs and amendments, new marketing applications, supplements/variations). Builds and maintains relationships across Regulatory Affairs, Operations, and R&D. Represents CMC on product development and Global Regulatory Product Teams and serves as strategic liaison with regulatory agencies (e.g., FDA) regarding CMC matters.

Responsibilities:
- Prepare CMC regulatory product strategies; develop and manage submissions (new applications/amendments/renewal annual reports, supplements, variations) and respond 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.
- Develop and manage CMC agency meeting strategies, pre-meeting submissions, and serve as point of contact.
- Manage products and change control; analyze and approve manufacturing change requests.
- Represent CMC regulatory affairs on project 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 CMC policies/procedures; lead internal initiatives.
- Represent CMC on cross-functional initiatives to drive efficiencies.
- Train, develop, and mentor individuals (may include supervisory responsibilities).

Qualifications:
- Bachelor’s Degree in Pharmacy, Chemistry, Biology or 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 with global regulatory strategies and Health Authority engagement.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.