Lead global regulatory strategy and shape the future of cancer innovation.
Proclinical is seeking a DGRA to support a key cancer program. This role will serve as the principal reg. authority and act as an independent contributor on project teams. This is a newly created role driven by high internal demand, offering an exciting opportunity to make a significant impact in the cancer space.
The position offers flexibility for remote work within Germany or the UK, with optional office access.
Responsibilities:
1. Lead global reg. strategies for oncology programs, ensuring alignment with organizational goals.
2. Act as the primary reg. representative on project teams, providing expert guidance and input.
3. Develop and execute reg. plans to support product development and approval processes.
4. Collaborate cross-functionally with internal teams and external stakeholders to ensure compliance with reg. requirements.
5. Prepare and review reg. submissions, including clinical trial applications and marketing authorization dossiers.
6. Stay updated on global reg. trends and changes, particularly in oncology, to inform strategic decisions.
Key Skills and Requirements:
7. Strong expertise in global reg. affairs, particularly within the oncology field.
8. Proven ability to lead reg. strategies and act as a key contributor on project teams.
9. Comprehensive knowledge of reg. submission processes and requirements.
10. Excellent communication and collaboration skills to work effectively with cross-functional teams.
11. Ability to manage multiple priorities in a fast-paced environment.
12. Flexibility to work remotely within Germany or the UK, with adherence to local contract regulations.