Associate Director, RA CMC

📋 Description

• The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with
• Develops CMC regulatory strategies to enable first pass approvals.
• Manages content strategy for regulatory submissions (INDs/CTAs, amendments, new marketing
• Represents CMC in cross-functional teams and communicates with regulatory agencies (e.g., FDA).
• Leads initiatives to drive efficiencies across Regulatory Affairs CMC and other functions.

🎯 Requirements

• Bachelor’s Degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field.
• 8 years pharmaceutical experience with at least 3 years of demonstrated leadership.
• 10 years pharmaceutical experience including regulatory affairs or related areas preferred.
• Experience developing global regulatory strategies and working with Health Authorities.
• Strong oral and written communication skills.

🎁 Benefits

• Comprehensive benefits package including paid time off and medical/dental/vision insurance.
• 401(k) retirement plan for eligible employees.
• Long-term incentive programs eligibility.