Associate Director - Regulatory Affairs

Proclinical; Greater London; Remote; GBP 90,000 - 120,000; Full time

Job summary

Proclinical is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategy and submissions for oncology development programs on a worldwide scale. This remote, contract-based role requires strong leadership in cross-functional planning and risk mitigation.

You will act as Global Regulatory Lead across development programs, aligning strategies with clinical, nonclinical, and CMC plans, and guiding health authority engagement, including designation applications like

Qualifications

• 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.

Responsibilities

• 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.
• 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.

Skills

Global regulatory leadership

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Scientific writing

Independent working

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

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 [e-mail].