Direct and manage all site activation and regulatory activities for assigned studies or multi‑protocol programmes
Act as a central point of contact for investigative sites, sponsors, and internal stakeholders
Contribute to business development and pre‑award activities
Develop and maintain Regulatory & Start‑Up Management Plans
Define and implement regulatory strategy, including submission requirements and authorisation pathways
Review, negotiate, and track regulatory and contractual documentation
Monitor site performance metrics and ensure compliance with SOPs, GCP, ICH, and applicable regulations
Collaborate across regions and countries to deliver multi‑regional and multi‑protocol programmes
Maintain accurate data in internal systems and project tracking tools
Mentor and coach team members and provide regulatory leadership and guidance
Build and maintain strong relationships with sponsors, investigative sites, and key customers
Deliver presentations or training to clients and colleagues where required

A Bachelor’s degree in Life Sciences or a related field
Typically 3–5 years’ relevant experience
Demonstrated experience working on international clinical trials
In‑depth knowledge of the clinical trial lifecycle, regulatory requirements, and drug development process
Strong understanding of GCP, ICH, and global regulatory guidelines
Excellent negotiation, communication, and interpersonal skills
Proven ability to lead through influence and deliver results across cross‑functional teams
Strong organisational, planning, and problem‑solving skills
Confidence using clinical systems and technology (e.g. CTMS)

You’ll play a pivotal role in bringing innovative therapies to patients
Opportunity to lead, influence, and grow within a highly respected clinical research organisation

Regulatory & Start-Up Manager

Key skills