Clinical Trial Regulatory Leader - Contract

Job Title: Clinical Trial Regulatory Leader

Location: Buckinghamshire

Duration: ASAP - 6 month contract

The Client: Global Pharmacuetical company

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Lead CTA Working Groups throughout entire CTA lifecycle
Provide country-specific input on document requirements, timing, and processes for CTA applications
Manage development of the CTA submission strategy for assigned trials
Drive interaction with local (country) staff to develop timelines and obtain locally-provided CTA documents
Complete locally-required activities, where applicable, such as application forms, applying for CTA numbers from Health Authorities, arranging for payment of fees
Ensure that all required centrally-produced required documents are included in the dossier
Liaise with publishing staff to ensure that country-specific dossiers are provided, including incorporation of locally-provided documents, as possible, in the completed dossier
Ensure dispatch of applications to Health Authorities (HAs) or other designated company representatives
Manage Health Authority Interactions for all (both central and local) CTA submissions (e.g., follow-up on status of application review with HAs; receive HA questions and coordinate responses appropriately, etc.)
Ensure that Regulatory staff (Global Regulatory Leader, Regional regulatory staff, Regional liaisons) and clinical trial staff are kept up-to-date on status of the application and HA queries throughout the project duration
Manage Output Protection Process for assigned trials
Ensure tracking of key information (including dates of submission and approval, status, HA requests and responses) occurs within CTA Tracking system
Manage/liaise with CROs as required

Full details available on application

The Candidate:

Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology. Ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry. An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.

Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur. Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency). Ability to lead complex projects and a high degree of problem solving capability required. Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills.

Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization. Must be able to work independently, strong initiative. May have to work remotely from supervisor.

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

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