Open role
Regulatory Affairs Manager Oncology CTA
- Aggregated by CV-Library
- Cambridge, Cambridgeshire
- Contract
- Full Time
- £164,250 - £178,850 Per Day
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
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