Regulator CTA Submission Manager
- Home Counties
- Contract
- Drug Safety / Pharmacovigilance
This vacancy has now expired
Are you looking for your next contract? Are you searching for that exciting CTA opportunity?
We have been appointed by our Pharmaceutical leader to search and a CTA lead for an exciting new project based in the desired location of leafy Buckinghamshire.
This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
- The Regulatory Clinical Trial Application submission manager has experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
- The Regulatory Clinical Trial Application submission manager will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
- Successful candidates for this position have: in depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.
We are offering a very competitive rate and the opportunity of working in a rewarding and exciting team.
If this is of interest to you, please do get in touch.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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