Hiring Now: Regulatory Affairs Manager Oncology CTA Near You – Apply Today!

Your Next Regulatory Affairs Manager Oncology CTA Job Starts Here – Apply Now!

Regulatory Affairs Manager Oncology CTA

Job Posted: 25 days ago

Salary: £ 450 - 490 / Day
Job Type: Contract
Location: Cambridge, Cambridgeshire

Expire in: 3 days

Job Description

An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to support innovative oncology and advanced therapy programmes within a global biopharmaceutical environment.

This role will play a key part in driving regulatory strategy, leading Clinical Trial Applications (CTA), EU CTR submissions, substantial amendments, and broader regulatory activities across EU. Working closely with global and regional stakeholders, you will support the development of cutting-edge therapies in a fast-paced, highly collaborative setting.
Key Responsibilities

Lead regulatory affairs activities for development-stage and marketed products.
Drive CTA submissions, amendments and EU CTR activities across Europe.
Develop and execute regulatory strategy in partnership with global regulatory teams.
Prepare and coordinate regulatory submissions in line with EU and ICH requirements.
Represent Regulatory Affairs within cross-functional project teams.
Monitor evolving European regulatory requirements and provide strategic guidance to stakeholders.
Experience Required

Proven experience within Regulatory Affairs in the pharmaceutical or biotech sector.
Strong knowledge of Clinical Trial Applications (CTA) and the EU Clinical Trials Regulation (EU CTR).
Experience developing and executing regulatory strategy for clinical development programmes.
Broad understanding of European regulatory requirements and procedures.
Experience supporting interactions with health authorities and cross-functional teams.
Oncology, cell therapy, ATMP or advanced therapy experience would be highly advantageous.
What's on Offer?

12-month contract with a leading global life sciences organisation, scope to extend.
Opportunity to support innovative oncology programmes and complex regulatory strategy activities.
Hybrid working with flexibility for the right candidate.
High-impact role working across Regulatory Affairs, clinical development and global project teams.
Please reach out and apply now if you'd like to hear more. 

Regulatory Affairs, Regulatory Manager, Regulatory Strategy, Oncology, CTA, Clinical Trial Applications, EU CTR, EU Clinical Trials Regulation, Advanced Therapies, ATMP, Cell Therapy, Clinical Development, Europe, Regulatory Submissions

Before You Apply

Do not include the following in your job application, CV, or cover letter:

Bank details.
National Insurance number.
Date of birth.

You should not be asked for payment or irrelevant information. If you have concerns about a job advert or employer, seek guidance on how to proceed.

Looking for your next career move? Join a top company hiring Regulatory Affairs Manager Oncology CTA job near me in Cambridge, Cambridgeshire! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!