Regulatory CTA Consultant
ProClinical is advertising an exciting opportunity to join a multinational biopharmaceutical company as a Regulatory CTA Consultant. The incumbent will join the company in their team in Uxbridge and become part of a family that prides itself on its innovative role in providing treatments for cancer and other severe conditions. This is a contract role.
The CTA Consultant will be responsible for new CTA applications in the company group, and for the maintenance of existing CTAs.
- Acting as the company lead for CTA preparation, specifically supporting the preparation of studies for 2 products.
- Supporting other team members with CTAs that are outsourced; for example, providing support in detailing country-specific requirements in different EU countries.
- Supporting the maintenance activities of legacy studies.
- Working with the product leads to develop CTA strategy and plans.
- Maintaining knowledge of current EU CTA-related regulatory guidance and procedures.
- Preparing the content of high-quality CTA dossiers, ensuring compliance with regulatory requirements.
- Reviewing and approving (if delegated by the EU regulatory product lead) key documents before submission.
- Ensuring that submission plans are captured appropriately.
- Ensuring that GRA, Regulatory Operations, and Affiliate Regulatory are updated in a timely manner, on CTA project plans, progress, and operational issues.
- Leading or participating in study team meetings as required.
Skills and Requirements:
- A Bachelor's degree in scientific discipline, or equivalent.
- Significant experience in the pharmaceutical industry.
- Demonstrably thorough 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.
- Excellent interpersonal skills, including oral and written communication, along with influencing, persuasion, and negotiation capabilities.
- Excellent organisational and time management skills needed to manage multiple on-going projects simultaneously.
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 call Peter Duvall on +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.
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