Senior Clinical Trial Manager (Regulatory)
Job Title: Senior Clinical Trial Manager (Drug Regulatory Affairs (DRA))
Schedule: Full-time (100%)
Start Date: ASAP
Contract Duration: 12 months
A leading pharmaceutical organisation is seeking a highly motivated Senior Clinical Trial Manager to support global regulatory activities related to clinical trials. This is a key role for someone with strong regulatory expertise and a proactive approach to ensuring clinical trial compliance across international markets.
Key Responsibilities:
Clinical Trial Applications (CTA):
* Provide regulatory input and guidance for clinical trials, liaising with internal departments, teams, and external service providers (ESPs).
* Prepare, submit, and maintain CTAs in line with European and international regulatory requirements.
* Coordinate document collection and submission with internal and regional staff and ESPs.
* Communicate directly with Health Authorities (HAs) regarding trial submissions and follow-ups.
* Ensure all CTA-related timelines are met, including responses to HA questions, amendments, End of Trial notifications, and submission of Clinical Study Report (CSR) synopses.
* Maintain submission tracking tools and ensure timely and accurate documentation in the Trial Master File (TMF), both electronic and paper-based.
Clinical Trial Team (CTT) Collaboration:
* Participate in CTT meetings, offering regulatory updates and support.
* Advise on country-specific timelines and submission priorities.
* Guide team members through submission processes and regulatory expectations.
* Keep CTT informed of all HA-related updates and share relevant documentation promptly.
Additional Responsibilities:
* Oversee submissions related to import/export licenses where applicable.
* Contribute to the development and refinement of internal SOPs and regulatory processes.
* Keep country-specific regulatory information current and share insights and best practices with colleagues.
* Provide training and support to new and existing DRA Clinical Trial Managers.
Candidate Requirements:
* 2+ years experience as a DRA Clinical Trial Manager or equivalent role in regulatory affairs
* Excellent organizational, communication, and time-management skills
* High attention to detail and a customer-oriented mindset
* Strong team spirit and collaborative approach
* Proficiency in Microsoft Office applications
* Fluent spoken and written English; knowledge of additional European languages is a plus
Interested? Apply now or please send your CV to megan@warmanobrien.com immediately. Applications closing 11/04/25.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research and Science
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Research Services
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