Regulatory Strategist Consultant UK & EU – Oncology

Contract Opportunity | Leading Oncology CRO | Remote/Flexible

We are seeking an experienced Regulatory Strategist Consultant to support a leading Oncology-focused Contract Research Organization (CRO). This role is ideal for a regulatory expert with a strong background in oncology drug development and global regulatory strategy.

Key Responsibilities:

• Develop and execute regulatory strategies for oncology programs, ensuring alignment with global health authority requirements (FDA, EMA, MHRA, PMDA).

• Provide strategic guidance on IND, NDA, BLA, MAA submissions and other regulatory filings.

• Advise on regulatory pathways, expedited programs (e.g., Fast Track, Breakthrough Therapy, Orphan Drug Designation), and early-phase development considerations.

• Collaborate with cross-functional teams, including clinical, CMC, and pharmacovigilance, to integrate regulatory insights into development plans.

• Lead or support health authority interactions, including preparation for pre-IND, Scientific Advice, and End-of-Phase meetings.

• Stay updated on evolving oncology regulations, industry trends, and regulatory intelligence to provide proactive guidance.

Key Requirements:

• Extensive experience in regulatory affairs, with a focus on oncology drug development.

• Strong knowledge of global regulatory guidelines (ICH, FDA, EMA, MHRA, etc.).

• Proven track record in regulatory strategy development and successful health authority submissions.

• Experience engaging with regulatory agencies and leading discussions on clinical and CMC strategies.

• Strong analytical, communication, and problem-solving skills.

• Ability to work independently in a fast-paced, consulting environment.

Assignment Details:

• Start Date: May

• Duration: 12-months 

• Location: Remote

• Engagement Type: Contract/Consulting - Outside IR35

This is an exciting opportunity to contribute to cutting-edge oncology programs with a leading CRO. If you are a seasoned regulatory strategist looking for a high-impact consulting role, we’d love to hear from you.