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Reference No: J12072

Regulatory Affairs Manager\Project Manager
Home-based or Surrey

Salary and Benefits:
•Private medical cover
•Private health insurance
•25 days holiday

We are working in partnership with a global CRO, who is seeking to fill positions for four Regulatory Affairs Managers/ Regulatory Affairs Project Managers to either be based in their office in Surrey, or home-based if Surrey is not a commutable distance. This company is recognised around the globe as the leader in clinical research and specialises in a wide range of therapeutic areas, including Paediatrics, Oncology and Immunology. They have recently promoted 300 of their 5000 worldwide staff and won some key projects and now keen to grow their Regulatory function.

These are permanent positions working within the EU remit, focusing on both Regulatory Affairs and Study Start-Up activities. The role of the Senior Regulatory Lead is to take the lead role across Europe for all Clinical Trial Regulatory Strategy pertaining to the study and to act as main point of contact between the Sponsor (Pharma companies) and the Study Start Up team & Regulatory local specialists. You will also be responsible for planning the submission strategy across Europe, for advising the client of timelines and managing their expectations and for preparing and submitting core Clinical Trial Applications and Ethics submissions.

Role duties:
Ensures that projects stay within contracted or client-approved scope within the Regulatory components of the project, timeline, and hours per task targets. Where applicable, notifies the Site Start-Up Lead (SSUL) if out-of-scope work is requested. Assumes responsibility on deliverables at the project level following the project requirements and the applicable rules.

Uses professionally recognized tools for planning and management of scope, timeline, resources, and budget within the Regulatory components of the project. Ensures that minimum hours are used for tasks and that the, SSUL or Project Manager (PM) or designee is pursuing out-of-scope work via the Change Order or financial reconciliation processes.

Assumes responsibility on deliverables at the project level following the project requirements and the applicable rules.

Interacts with the SSUL, PM, or designee to understand financial aspects of the project; cascades to all start-up team members the number of hours/tasks available per contract; monitors project performance.

Reviews contractual project specifications; obtains resource commitments and monitors the resource performance versus the Regulatory plan.

Collaborates on standards, processes, and expectations with internal and external customers. Meets all appropriate revenue and productivity targets set.

Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities.

Prepares the core clinical trial application dossier. Complies with forecasted submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, solves or escalates the problem quickly.

Candidate criteria:
•Extensive experience as main point of contact with sponsor (Pharma client for clinical trial regulatory strategy)
•Proven experience developing strategy for global clinical trial submissions
•Experience in the preparation and review of core documents
•Ethics Committee and regulatory authority submissions experience across Europe is essential.

If this role sounds appealing, please contact Ridda Michail at Regulatory Professionals on 0118 9522797 or email

As there is more than one role please don’t forget about our excellent referral bonus of £250 in vouchers for anyone you newly refer to us who then gets placed in a role!

Please find the link to the results of our salary survey for 2014: – a complementary hard copy can be ordered from the website.

Key words: Home-based Home based SSU start-up study start up study Senior Regulatory Affairs team leader project manger CRO EU Clinical Trial Application CTA Ethics Submission Surrey London Kent Sussex Hampshire Berkshire

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