Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Senior Regulatory Clinical Trial Application Submission Manager based in High Wycombe. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries. 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 will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team (CTA Working Group [WG]) that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
- The CTA submission manager will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
- The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- The CTA submission manager manages the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
- If Clinical Research Organizations are contracted to handle some (or all) aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staff, as required.
Skills and Requirements:
- 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 skills.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.