Senior Specialist, Regulatory Affairs
ProClinical is advertising a vacancy for a Senior Specialist, Regulatory Affairs position with a major biotechnology company that prides itself on its extensive pipeline and commercial portfolio in oncology and immunology. The position is with the company's office in Uxbridge. This is an exciting opportunity to join an innovative company that delivers life-changing drugs with over 4000 employees in over 50 countries worldwide.
- Supporting the execution and delivery of EU regulatory strategies for other assigned projects (e.g. licence variation applications, PIP modifications).
- Supporting the execution of development and submission strategies in the EU for assigned projects, by contributing to the development and preparation of high-quality regulatory CTA dossiers and other dossiers (e.g. licence variation applications, PIP modifications, DSUR applications, IB updates), ensuring compliance with regulatory requirements.
- Supporting the maintenance activities of existing studies (amendments, DSUR applications, IB updates, TMF reviews).
- Working with the Regional Regulatory Leads to develop CTA strategy and plans.
- Contributing to the content of regulatory documents working with other functions as necessary and contributes to the review of documents before submission.
- Supporting the delivery of Content Plans to allow publishing and timely dossier submission.
- Taking responsibility for tracking activities, projects and timelines, managing deliverables and for accurate submission plans.
- Identifying and communicating to manager any emerging issues that may impact company business.
- Ensuring that copies of regulatory documents such as contact reports with regulatory agencies are archived.
- Identifying any learning or best practice and communicating to manager.
- Developing knowledge of current EU regulatory guidance and procedures.
Skills and Requirements:
- Bachelor's degree in scientific discipline or equivalent required.
- Pharmaceutical industry experience required.
- Significant experience of CTA applications required.
- Basic understanding of current EU regulatory processes 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 in MS Office.
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.
US$0.00 - US$73000.00 per annum
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