Regulatory Affairs Manager Oncology CTA
H
Hays Life Sciences
📍 Cambridge, Cambridgeshire, United Kingdom
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 evol...
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 evol...