Regulatory Affairs Senior Associate
A leading biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Regulatory Affairs Senior Associate job opportunity at their offices in Uxbridge. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
- Prepare regulatory submissions for investigational and commercial products in the Respiratory/Inflammation therapeutic area.
- Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/ amendments and attend Clinical Study Management (SMT) meetings, as required.
- Prepare and/or co-ordinate the submission of non-clinical, clinical, and safety regulatory documentation in accordance with regulations, post licensing commitments, and legal obligations of the marketing Authorisation Holder via the European Centralised procedure, e.g. variations, PSURs, RMPs, responses to questions and renewals etc.
- Support scientific advice procedures and Paediatric Investigation Plans (PIP) in the European Union.
- Interact with the US regulatory, Clinical Research, and Clinical Operations team leads to ensure optimal execution of the agreed regulatory strategy for development medicinal products.
- Represent International Regulatory function at cross functional submission/study management team meetings.
- Ensure product packaging and associated information is updated and maintained in accordance with product licenses, in international territories, including the review of artwork and the provision of accurate labelling translations.
- Provide advice and practical input on labeling issues across the development and marketed product portfolio.
- Maintain a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams and senior management.
- Participate in regulatory team meetings and present project status updates.
Skills and Requirements:
- Degree in biological/life sciences, pharmacy or medicine. An advanced degree is desirable.
- Experience in the preparation and submission of regulatory documentation to support clinical trials applications/amendments in the European Union and a good breadth of understanding of European regulations relating to clinical trials.
- An understanding of the regulatory requirements for the EU centralized procedure, together with experience in post-licensing management of products is preferable.
- Must be able to facilitate effective interactions within the International Regulatory Department, as well as with other departments and sites within the Company (for example, Clinical Research and Pharmacovigilance and Epidemiology), and Gilead affiliates and distributors
- Experience representing Regulatory Affairs on cross-functional teams is desirable.
- Able to facilitate/lead, impact and influence effective strategic planning interactions and discussions.
- Ability to work under minimal supervision of Regulatory Affairs professionals but following detailed instruction with well-defined procedures.
- Ability to understand and effectively relate to external and internal customers.
- Experience with working with document management systems.
- A good knowledge of the therapeutic area or a good scientific background and understanding with the ability to acquire this knowledge in a short timeframe.
- 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.
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 Alex Czuprynski at +44 203 869 2329 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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