PEGlobal are currently seeking a Regulatory Clinical Trial Application Submission Manager for our multinational pharmaceutical client based in Buckinghamshire area.
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).
- 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.).
- Submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
- Responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- Initiates the Drug Release 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.
- Integrates information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriate.
Education & Experience:
- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required.
- 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.