Associate Director - Regulatory Affairs / Associate Director - Regulatory Affairs

Join Our Team as an Associate Director of Regulatory Affairs

Are you 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 become part of a dynamic team in the oncology and pharmaceutical sector. This role is essential for guiding global regulatory strategies and submissions for development programs. This position is remote and contract-based, requiring expertise in regulatory affairs and a robust ability to navigate cross-functional collaboration.

Key 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 the 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 (annual reports, etc.).
  • Ensure regulatory alignment across clinical, nonclinical, and CMC components of submissions while maintaining coordination among internal teams to support submission timelines.
  • Oversee 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 submissions, agency correspondence, and follow-ups 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 the 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 a related discipline required; advanced degree preferred.
• Minimum of 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience.
• Experience in Radiopharmaceuticals is beneficial.
• Demonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for early and late clinical development programs.
• Experience with EMA and CTIS preferred.
• Strong scientific/medical writing skills, capable of condensing scientific information and data into regulatory narratives.
• Ability to operate effectively and independently in a fast-paced clinical development environment.

Apply Online

If you are interested in this exciting opportunity, apply online using the form below. Please note that only applications matching the job profile will be considered.

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