Associate Director, Regulatory Affairs - CMC

📋 Description

• Manage internal regulatory processes and prepare submissions per global health authority regs.
• Develop global CMC regulatory strategies with leadership and CMC SMEs.
• Collaborate with cross-functional teams to assemble CMC sections of regulatory dossiers (ROW).
• Coordinate timelines and manage author, review, and approval workflows.
• Provide RA CMC support for Health Authority interactions, including drafting.
• Maintain knowledge of global regulations and standards for drug development.

🎯 Requirements

• Bachelor’s degree required; life sciences preferred.
• 7+ years in pharmaceutical regulatory affairs or CMC.
• Excellent communication and attention to detail.
• Independent project management with limited supervision.
• Proficient with Microsoft Office; Veeva experience; AI tools.
• Self-starter with initiative and ability to influence.

🎁 Benefits

• Market-leading compensation.
• 401(k) with employer match.
• ESPP (Employee Stock Purchase Program).
• 100% employer-paid medical, dental, and vision for you and dependents.
• Pre-tax commuter benefits and subsidized meals/parking on in-office days.
• Hybrid work model with flexible PTO and holidays.