Associate Director - Regulatory Affairs

Ready to lead global regulatory strategy and influence the development of innovative oncology therapies on a worldwide scale?

Proclinical is seeking an Associate Director of Regulatory Affairs to join a dynamic team in the oncology and pharmaceutical sector. In this role, you will play a key part in leading global regulatory strategies and submissions for development programs. This is a remote, contract-based position requiring expertise in regulatory affairs and a strong ability to navigate cross-functional collaboration.

Responsibilities

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 crossfunctional planning of regulatory submissions and amendments including ongoing lifecycle management activities (annual reports etc).
• Ensure regulatory alignment across clinical, nonclinical, and CMC components of submissions and ensure alignment between internal teams to support submission timelines.
• Lead strategic planning and preparation for regulatory interactions, develop 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.
• Experience in Radiopharmaceuticals would be beneficial
• 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.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at

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Required Skills

regulatory affairs global regulatory strategy submissions health authority engagement cross-functional collaboration

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