Associate Director, RA CMC

Purpose:
- Works with internal and external partners to deliver products to patients.
- Prepares CMC regulatory strategies enabling first pass approvals.
- Develops content strategy for regulatory submissions (INDs/CTAs and amendments, new marketing applications, supplements/variations).
- Builds/maintains relationships across Regulatory Affairs, Operations, and R&D.
- Represents CMC on product development, Global Regulatory Product Teams, and Operations brand teams; negotiates, influences, and provides strategic advice.
- Serves as liaison with regulatory agencies (e.g., FDA) on CMC matters.

Responsibilities:
- Prepares and manages CMC regulatory submissions (new applications, amendments, renewals annual reports, supplements/variations) and responses to regulatory information.
- Analyzes and interprets information impacting regulatory decisions; seeks expert/technical support as needed.
- Reviews and revises submissions to present data and strategy effectively to regulatory agencies.
- Develops CMC strategies for agency meetings; manages meeting preparation and pre-meeting submissions; serves as point of contact.
- Manages products and change control; analyzes and approves manufacturing change requests.
- Represents CMC regulatory affairs on assigned project teams; negotiates and influences stakeholders to maximize first pass approval.
- Stays current on regulatory procedures and climate; analyzes legislation/regulation/guidance and provides organizational input.
- Develops, implements, and documents RA department policies/procedures; leads RA CMC initiatives.
- Represents CMC on cross-functional initiatives to drive efficiencies.
- Trains, develops, and mentors individuals (may include supervisory responsibilities).

Qualifications:
- Required Education: Bachelor’s degree in Pharmacy, Chemistry, Biology/Pharmacology, Engineering, or related field.
- Preferred Education: Relevant advanced degree; certification a plus.
- Required Experience: 8 years in pharmaceuticals 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/implementing global regulatory strategies; experience working with Health Authorities.
- Experience in complex, matrix environments.
- Strong oral and written communication skills.

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