Regulatory Clinical Trials Submission Manager - United Kingdom - ProPharma

Description

ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving pharmaceutical, biotechnology, and medical device companies.

Our team of experts brings a comprehensive portfolio of regulatory sciences, clinical research solutions, life science consulting, R&D technology, pharmacovigilance, and medical information services to help solve complex challenges in a dynamic regulatory environment.

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

The Manager, Clinical Trial Submissions, Regulatory Sciences will be responsible for leading and managing submission activities for approval and maintenance of clinical trials for clients.

This role will collaborate closely with cross-functional teams (internal and external to ProPharma) to ensure compliance with applicable regulations and guidelines.

Responsibilities Lead the regulatory European and UK CTA submission processes from start to finish for multiple clients and projectsLead/support more specialist clinical submission projects (IVD performance study applications, GMO applications etc)Coordinate and manage multiple projects simultaneously while ensuring deadlines are metManage/mentor more junior regulatory colleagues and provide guidance to ensure successful project completionAct as a client liaison and represent ProPharma in a professional and effective mannerCollaborate with cross-functional teams and stakeholders to ensure project successEnsure all regulatory documents are accurate and comply with relevant regulationsIf you're an experienced regulatory specialist who is passionate about delivering exceptional service to clients and enjoys working in a fast-paced, dynamic environment, we want to hear from you.