Associate Director, Regulatory Affairs

Responsibilities:
- Contribute to development and execution of regulatory strategies for assigned programs; serve as regulatory lead for assigned clinical studies
- Identify potential regulatory risks and develop mitigation approaches
- Provide regulatory guidance to cross-functional product development teams (study operating teams and workstreams)
- Lead preparation, review, and timely submission of high-quality, compliant regulatory documents (INDs, CTAs, amendments; NDAs, supplements) and moderately complex regulatory submissions
- Contribute to internal regulatory process improvements (processes, operating guidelines, templates, best practices)
- Support preparation for health authority interactions, including briefing packages and response documents
- Participate in agency communications and help track commitments and action items
- Stay current with evolving global regulatory requirements and assess potential program impact
- Ensure regulatory activities comply with applicable regulations and company procedures

Qualifications:
- Bachelor’s degree required (preferably scientific); advanced degree is a plus
- 8+ years drug development; 5+ years regulatory affairs experience in biotech/pharma
- Working knowledge of global regulatory requirements (FDA, EMA, ICH) and GXP
- Experience supporting regulatory submissions (e.g., IND/CTA/eCTD) and health authority interactions
- Ability to manage multiple priorities and collaborate across teams and external partners
- Excellent written/verbal communication and strong organizational/product coordination skills

Pay Range (U.S.): $200,700–$234,150 per year.