Regulatory & Start-Up Manager

Clinical Operations | Regulatory & Site Activation

Location: Flexible / office‑based depending on project needs
Travel: Occasional travel may be required

Contract Length: 4- 6 months

Are you an experienced Regulatory & Start‑Up professional looking to lead complex clinical trial start‑up activities across global or multi‑regional studies? We are seeking a Regulatory & Start‑Up Manager to take ownership of site activation, regulatory strategy, and ongoing site maintenance for high‑profile clinical research programmes.

This is a key role within Clinical Operations, providing leadership, oversight, and subject‑matter expertise to ensure studies are delivered compliantly, efficiently, and on time.

The Role

As Regulatory & Start‑Up Manager, you will direct and manage all site activation and regulatory activities for assigned studies or multi‑protocol programmes. You will act as a central point of contact for investigative sites, sponsors, and internal stakeholders, ensuring regulatory and contractual requirements are met throughout start‑up and maintenance phases.

You will also contribute to business development and pre‑award activities, providing regulatory insight and solutions to support successful bids and study delivery.

Key Responsibilities

• Lead and oversee site activation and maintenance activities, including pre‑award and bid defence support
• Develop and maintain Regulatory & Start‑Up Management Plans in line with project scope, timelines, and strategy
• Define and implement regulatory strategy, including submission requirements and authorisation pathways
• Review, negotiate, and track regulatory and contractual documentation to ensure full execution
• 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
• Assess regulatory complexity and provide creative, practical solutions to operational challenges
• Maintain accurate data in internal systems (including CTMS) 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
• Support monthly study budget planning and reviews, as needed

About You

You are a confident regulatory leader with strong stakeholder management skills and the ability to balance multiple, complex priorities.

You will bring:

• A Bachelor’s degree in Life Sciences or a related field
• Typically 3–5 years’ relevant experience, with broader experience (up to 7+ years) in a scientific or clinical research environment preferred
• 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)
• The ability to work proactively, exercise sound judgement, and manage competing priorities

Why Join Us?

You’ll play a pivotal role in bringing innovative therapies to patients, working on complex global studies within a collaborative and supportive environment. This role offers the opportunity to lead, influence, and grow within a highly respected clinical research organisation.

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