Job Description

Job Description

Associate Director Regulatory Affairs

Our client is seeking an experienced Associate Director of Regulatory Affairs to lead clinical regulatory strategy for a portfolio of small-molecule drug programs progressing from late clinical development through NDA submission and approval. This role is highly strategic and cross functional, serving as the regulatory lead for clinical development planning, FDA engagement, and NDA execution. The successful candidate will be deeply embedded in clinical development, partnering closely with Clinical Development, Clinical Operations, Biostatistics, Medical Affairs, and Commercial teams.

The Director of Regulatory Affairs will be responsible for leading the clinical regulatory strategy for small-molecule programs, ensuring alignment between regulatory strategy, clinical execution, and commercial objectives.

Responsibilities

• Develop and own the global clinical regulatory strategy for small-molecule programs from IND through NDA submission and approval.
• Provide regulatory leadership on clinical development plans, study designs, endpoints, and protocol strategy to support approvability.
• Ensure alignment between regulatory strategy, clinical execution, and commercial objectives.
• Serve as the primary regulatory lead for FDA interactions, including End-of-Phase 2 meetings and Pre-NDA meetings
• Advisory Committee preparation (as applicable)
• Prepare and lead briefing packages, meeting requests, responses to FDA questions, and follow-up commitments.
• Labelling strategy and negotiations and risk-benefit assessments
• Partner with Regulatory Operations to ensure timely, high-quality NDA submissions.
• Act as the regulatory voice on clinical development teams, providing real-time regulatory guidance and risk assessment.
• Monitor evolving FDA guidance and regulatory precedents relevant to small-molecule NDAs.
• Identify regulatory risks early and propose mitigation strategies.
• Contribute to long-range regulatory planning and portfolio prioritization.

Qualifications

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
• 6 - 10 years of Regulatory Affairs experience with a strong emphasis on clinical regulatory strategy.
• Demonstrated leadership of IND-to-NDA pathways for small-molecule drugs.
• Experience in FDA meetings and influencing clinical development decisions.
• Proven ability to work cross-functionally and influence senior stakeholders.
• Prior experience leading or contributing to successful NDA approvals.
• Experience in fast-paced biotech or pharmaceutical environments.
• Familiarity with global regulatory considerations (EMA, MHRA) is a plus but not required.

If interested, please Easy Apply below or reach out to Conner.Harman@Codon -Partners.com

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