Clinical Trial Application Submission Manager
- M4 Corridor
- Contract
- Drug Safety / Pharmacovigilance
This vacancy has now expired
Our global client based in leafy West London has now engaged with Quanta's services to assist them with a new search for a Regulatory Clinical Trial Application Submission Manager which will be home based.
This new and exciting project will be for a period of one year with a start date at the beginning of January 2022.
Duties will include the following:
- 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.
- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology. 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.
- Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur. Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency). Ability to lead complex projects and a high degree of problem solving capability required. Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skillss
- Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization. Must be able to work independently, strong initiative. May have to work remotely from supervisor.
If this is of interest, please do get in touch
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
To view Quanta's privacy policy, please visit our website
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing'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 QCS Staffing'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
I have always received a highly professional & personable service from the team at QCS Staffing. 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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