Regulatory Affairs Associate - III
A vacancy has arisen for a Human Resources Assistant with an internationally renowned pharmaceutical company, based in their UK office. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organization and support their innovative impact on the healthcare field.
- Supporting 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.
- Preparing and/or coordination of regulatory labelling variation submissions for the company's marketed products in line with corporate objectives.
- Assisting 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.
- Supporting the preparation/maintenance of clinical trial applications, ROW core dossiers, and response to ROW questions.
- Representing International Regulatory Affairs (Int RA) function at cross functional submission/ study management team meetings.
- Participating in regulatory HIV team meetings, product team meetings, and departmental meetings.
- Using and updating regulatory information systems for planning, preparing, tracking, and storing submissions to regulatory agencies.
- Supporting the HIV Int RA team as required.
Skills and Requirements:
- A good scientific background and understanding.
- 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 Centralized products is desirable.
- Experience with working with document management systems (RDMS / SIMS).
- Business awareness and professionalism.
- 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 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 Staffing 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.