Regulatory Clinical Trial Application Submission
- Home Counties
- Contract
- Drug Safety / Pharmacovigilance
This vacancy has now expired
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.
Successful candidates for this position have:
- In depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.
- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required
- The ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry. An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.
For the right candidate, the client has assured that after the initial on-boarding period, some remote working will be possible.
Please contact me for further details or to apply.
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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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
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
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
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Kathryn
I manage this role.