Regulatory Affairs 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 Associate job. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
- Support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.
- Preparation and/or coordination of regulatory labelling variation submissions for the company's marketed products in line with corporate objectives.
- Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in international territories including the review and provision of accurate labelling translations.
- Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions.
- Represent International Regulatory Affairs (Int RA) function at cross functional submission/ study management team meetings.
- Participate in regulatory HIV team meetings, product team meetings and departmental meetings.
- Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
- Support the HIV Int RA team as required.
Skills and Requirements:
- Life sciences degree.
- Relevant experience in Regulatory Affairs.
- An understanding of regulatory requirements for the EU centralised procedure.
- Experience in supporting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc for Centralised products is desirable.
- Experience with working with document management systems (RDMS / SIMS).
- Able to facilitate/impact and influence effective interactions and discussions.
- Able to effectively interact to information gather and effectively drive projects through to completion to tight timelines.
- A good scientific background and understanding.
- Excellent planning skills with the ability to work simultaneously on a number of projects with tight timelines.
- Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
- Problem solving, strategic thinking skills with the ability to impact and influence.
- Attention to detail with accuracy and quality.
- Demonstrable multitasking, project management, and execution skills.
- Good time management, client-focused and strong attention to detail.
- 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 Peter Duvall at 0203 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.