Director Global Regulatory Affairs (Oncology)

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:

• Lead global reg. strategies for oncology programs, ensuring alignment with organizational goals.
• Act as the primary reg. representative on project teams, providing expert guidance and input.
• Develop and execute reg. plans to support product development and approval processes.
• Collaborate cross-functionally with internal teams and external stakeholders to ensure compliance with reg. requirements.
• Prepare and review reg. submissions, including clinical trial applications and marketing authorization dossiers.
• Stay updated on global reg. trends and changes, particularly in oncology, to inform strategic decisions.

Key Skills and Requirements:

• Strong expertise in global reg. affairs, particularly within the oncology field.
• Proven ability to lead reg. strategies and act as a key contributor on project teams.
• Comprehensive knowledge of reg. submission processes and requirements.
• Excellent communication and collaboration skills to work effectively with cross-functional teams.
• Ability to manage multiple priorities in a fast-paced environment.
• Flexibility to work remotely within Germany or the UK, with adherence to local contract regulations.