Regulatory Affairs Associate
ProClinical is excited to announce a vacancy for a Regulatory Affairs Associate with a pioneer in the biotechnology field. This company specialises in the discovery, development, and delivery of innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. They are seeking a talented and hard-working individual to join their UK-based team in Berkshire on a contract basis.
The Regulatory Affairs (RA) Associate will be responsible for overseeing artwork updates and change management for EU marketed products. They will be responsible for assisting in planning and preparing submissions to regulatory authorities.
- Initiating and maintaining oversight of artwork updates for EU marketed products via emails and in relevant systems.
- Acting as point of contact with the artwork team for all products, providing oversight and heading change management meetings.
- Reviewing and approving artwork mock ups for product launches as required.
- Onboard new EU Affiliates and Distributors.
- Overseeing regulatory systems and participating in system improvement workstreams.
- Assisting in the planning and preparing of regulatory submissions relevant to assigned projects or programs.
- Preparing and delivering effective presentations for internal audiences.
- Contacting regulatory agencies relevant to assigned projects or programs, as appropriate.
- Participating in discussions surrounding regulatory strategy.
- Representing RA affairs on relevant teams, as appropriate.
- Participating in the improvement of interdepartmental communications.
- Developing and writing department SOPS.
Skills and Requirements:
- A Bachelor's degree, preferably in a Life or Health Science field.
- Demonstrable experience/knowledge in the oversight of artwork updates, change management, or preparation of regulatory submissions.
- Demonstrable cross-cultural and cross-functional awareness.
- Implementable knowledge and understanding of applicable regulations.
- Able to act with a sense of urgency and showing capabilities of working both independently and in a team.
- Good communication skills, with the ability to influence and persuade others both internally and externally.
- Computer proficiency/literacy
- An ability to maintain demanding timelines.
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 Numhom Sudsok on +44 203 871 8093 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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