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 p.duvall@proclinical.com.
#J-18808-Ljbffr
Associate Director - Regulatory Affairs employer: ProClinical
Join a globally recognised biopharmaceutical organisation that prioritises innovation and collaboration in the field of protein science and biologic drug development. With a strong commitment to employee growth, you will have access to continuous learning opportunities and be part of a supportive team dedicated to delivering life-changing therapies. Located in a vibrant area, this role not only offers meaningful work but also a dynamic work culture that values your contributions and fosters professional development.
