Associate Director, Regulatory Affairs CMC

Olema Oncology is seeking an Associate Director, Regulatory Affairs CMC to develop and execute CMC regulatory strategies for product(s) in development and post-approval, working closely with cross-functional teams to ensure regulatory compliance and high-quality submissions.

Requirements

• Develop and execute CMC regulatory strategies for product(s) in development and post-approval
• Provide guidance and oversight for development of high-quality and on-time CMC sections of regulatory submissions
• Support regulatory agency interactions to ensure alignment on CMC strategies
• Provide CMC regulatory expertise for global development and registration programs
• Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines

Benefits

• Competitive compensation and benefits package
• Equity, bonus, and benefits
• Flexible and friendly work environment
• Open and transparent communication