Regulatory Affairs Manager Oncology
JOB_53433114724762Job type
ContractLocation
UxbridgeWorking Pattern
Full-timeSpecialism
Regulatory AffairsIndustry
PharmaceuticalsPay
£400-480 per day (Umbrella)
Regulatory Affairs Manager – Oncology | 18-Month Contract | Hybrid (Cambridge or Stockley Park)
Location: 3 days on-site in either Cambridge or Stockley Park
Contract Length: 18 months
Start Date: Handover required by mid-November
Industry: Biopharmaceuticals
Therapeutic Area: Oncology
Contract Length: 18 months
Start Date: Handover required by mid-November
Industry: Biopharmaceuticals
Therapeutic Area: Oncology
We’re seeking a Regulatory Affairs Manager to support a leading biopharma company (client confidential) on an 18-month contract. This is a high-impact role focused on regulatory strategy and submissions for oncology products in development and/or commercial stages.
Key Responsibilities
- Act as Regional Regulatory Lead for assigned oncology products or indications.
- Lead Regulatory Submission Teams and represent Regulatory Affairs in cross-functional project teams.
- Prepare and manage CTA (Clinical Trial Applications) and MAA (Marketing Authorisation Applications).
- Oversee regulatory documentation including INDs, DSURs, Investigator Brochures, and label updates.
- Liaise with regulatory authorities and support interactions and meetings.
- Provide strategic input and ensure compliance with ICH guidelines and local regulatory requirements.
- Mentor junior team members and contribute to process improvements.
Essential Experience
- Proven track record in oncology regulatory affairs within the biopharma industry.
- Strong experience with CTA and MAA submissions in the EU and/or UK.
- Familiarity with ICH standards, regulatory strategy, and health authority engagement.
- Ability to work cross-functionally and lead regulatory projects independently.
- Excellent communication, writing, and project management skills.
Qualifications
- Degree in Life Sciences (B.Sc., M.Sc., PhD, PharmD or equivalent).
- 6+ years of relevant regulatory experience, ideally in oncology.
- Experience in a matrixed environment and working with global teams.
Why This Contract?
- Long-term stability with an 18-month engagement.
- Opportunity to work on high-profile oncology programs.
- Hybrid flexibility with a collaborative on-site team.
- Competitive day rate and fast onboarding.
Interested?
Apply now or reach out for a confidential discussion. Interviews and onboarding will begin shortly, with a handover planned for mid-November.
Apply now or reach out for a confidential discussion. Interviews and onboarding will begin shortly, with a handover planned for mid-November.
Regulatory Affairs Manager OncologyJOB_534331147247622025-09-162025-12-14
Talk to Julia Bowden, the specialist consultant managing this position
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JOB_53433114724762