Regulatory & Start-Up Manager

Clinical Operations Regulatory & Site Activation

Location: Flexible / officebased depending on project needs
Travel: Occasional travel may be required

Contract Length: 4- 6 months

Are you an experienced Regulatory & StartUp professional looking to lead complex clinical trial startup activities across global or multiregional studies We are seeking a Regulatory & StartUp Manager to take ownership of site activation regulatory strategy and ongoing site maintenance for highprofile clinical research programmes.

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

The Role

As Regulatory & StartUp Manager you will direct and manage all site activation and regulatory activities for assigned studies or multiprotocol 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 startup and maintenance phases.

You will also contribute to business development and preaward activities providing regulatory insight and solutions to support successful bids and study delivery.

Key Responsibilities

• Lead and oversee site activation and maintenance activities including preaward and bid defence support
• Develop and maintain Regulatory & StartUp 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 multiregional and multiprotocol 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 Bachelors degree in Life Sciences or a related field
• Typically 35 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
• Indepth 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 crossfunctional teams
• Strong organisational planning and problemsolving 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

Youll 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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