Associate Director, RA CMC

📋 Description

• Lead CMC regulatory strategies to enable first pass approvals
• Develop and manage content for regulatory submissions (INDs/CTAs, amendments, marketing
• Collaborate with Regulatory Affairs, Operations, and R&D to drive product development and
• Represent CMC in meetings with product teams and regulatory agencies (e.g., FDA)
• Oversee change control and product lifecycle regulatory activities
• Mentor and train team members; may include supervisory responsibilities

🎯 Requirements

• Required: Bachelor's in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related
• 8 years pharma experience with at least 3 years leadership
• Preferred: advanced degree; certification a plus
• 10 years pharma with 5+ years in RA/Discovery/R&D/Manufacturing
• Experience with global regulatory strategies and Health Authority interactions
• Strong communication skills; ability to work in matrix environments

🎁 Benefits

• Comprehensive package including PTO, medical/dental/vision, 401(k)
• Eligible for long-term incentive programs
• Equal opportunity employer; relocation and visa sponsorship policies described in the posting