Associate Director of Regulatory Affairs

Job Summary

A company is looking for an Associate Director, Regulatory Affairs.

Key Responsibilities

• Develop and execute global regulatory strategies for clinical development and marketing approvals
• Lead the preparation and submission of regulatory documents and applications across multiple regions
• Collaborate with cross-functional teams to ensure regulatory alignment and monitor evolving regulations

Required Qualifications

• Bachelor's degree; RAC certification is a plus
• 8+ years of experience in the biopharmaceutical industry, with at least 5 years in regulatory roles
• Experience with multinational late-stage clinical trials and interactions with ex-US health authorities
• Familiarity with biologics development and regulatory frameworks for biological products
• Proven track record in authoring major regulatory submissions and managing multi-country regulatory filings