Associate Director - Regulatory Affairs

Lead Global Regulatory Strategy for Innovative Oncology Therapies

Join a dynamic team in the oncology and pharmaceutical sector to influence the development of innovative therapies on a worldwide scale. In this remote, contract-based role, you will play a key part in leading global regulatory strategies and submissions for development programs. This position requires expertise in regulatory affairs and a strong ability to navigate cross-functional collaboration.

Regulatory and Program Oversight

• Serve as Global Regulatory Lead for development programs across the portfolio.
• Develop, maintain, and execute program-level regulatory strategies aligned with corporate objectives and stage of development.
• Identify regulatory risks and develop mitigation strategies aligned with clinical, nonclinical, and CMC development plans.

Regulatory Submission Planning and Health Authority Engagement

• Lead cross-functional planning of regulatory submissions and amendments, including ongoing lifecycle management activities such as annual reports.
• Ensure regulatory alignment across clinical, nonclinical, and CMC components of submissions and coordinate internal teams to support submission timelines.
• Lead strategic planning and preparation for regulatory interactions, developing regulatory questions, meeting objectives, and overall regulatory positioning to guide health authority engagement and inform development decisions.
• Manage submission, agency correspondence, and follow-up related to regulatory designations.
• Document, interpret, and integrate health authority feedback into regulatory and development strategy, and coordinate responses to health authority requests.
• Author and lead preparation of regulatory designation applications, such as Orphan Drug, Fast Track, and other applicable expedited programs.

Key Skills and Requirements

• Bachelor's degree in life sciences or related discipline required; advanced degree preferred.
• Minimum of 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience.
• Demonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for early/late clinical development programs.
• Experience with EMA and CTIS preferred.
• Experience with radiopharmaceuticals preferred.
• Strong scientific/medical writing skills, with the ability to condense scientific information and data into regulatory narratives.
• Ability to operate effectively and independently in a fast-paced, clinical development environment.