Regulatory CTA Consultant

A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Regulatory CTA Consultant to join their Uxbridge team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide. This is a contract position.

Job Responsibilities:

• Acts as the MM group lead for CTA preparation.
• Will support other team members with CTAs that are outsourced, for example, in providing support in detailing country-specific requirements in different EU countries.
• Will support the maintenance activities of legacy studies.
• Working with the product leads to develop CTA strategy and plans.
• Maintains knowledge of current EU CTA-related regulatory guidance and procedures.
• Accountable for the preparation and content of high-quality CTA dossiers, ensuring compliance with regulatory requirements. Reviews and approves (if delegated by the EU regulatory product lead) key documents before submission.
• Accountable for ensuring that submission plans are captured appropriately.
• Accountable for ensuring that GRA, Regulatory Operations and Affiliate Regulatory are kept updated in a timely manner, on CTA project plans, progress and operational issues.
• Leads or participates in study team meetings as required.

Skills and Requirements:

• Bachelor's degree in scientific discipline or equivalent required.
• Significant experience in the pharmaceutical industry, including a good understanding of the drug development process and the roles of the different functions and stakeholders involved.
• Significant experience in European RA with an in-depth knowledge of EU Clinical Trial Requirements.
• Experience in Haematology/Oncology preferred.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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