Due to ongoing growth in our clients product portfolio and entry into new markets, they have exciting opportunities in our Regulatory Affairs team for scientists who wish to put their knowledge and training to use in a fast-paced, results-focused commercial R&D environment.
The Regulatory Affairs team are responsible for obtaining and maintaining product registrations for products, based on exacting regulatory requirements. Currently working across EU markets, success comes in the form of achieving and retaining the authorisation of products, through a variety of documentation.
These roles will be a fundamental part of the R&D team, and the Regulatory Affairs Executive will be responsible for key deliverables, fundamental to the company’s long-term strategies in European and global markets.
- Preparation, review and approval of regulatory submissions for new product applications
- Maintenance of existing authorisations across a number of countries
- Liaise with regulatory authorities, external consultants, CROs, test facilities and other internal departments (e.g. laboratory) in support of product authorisations
- Work with other regulatory teams to determine approval pathways to new markets
- Regulatory affairs representative on cross-functional project teams
- Preparation and review of guidance documents
- Confidential management of sensitive and technical information, along with collating and communicating data to team members
- Any other tasks deemed appropriate by Regulatory Affairs Manager
- Excellent academic record in a life sciences discipline, e.g. BSc (mandatory), preferably chemistry-based, minimum 2.1
- Minimum of 2-3 years’ experience in regulatory affairs, ideally within an industrial setting
- Ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic
- Perform tasks in an accurate, timely and efficient manner
- Excellent attention to detail is a must
- Ability to work on own initiative or as part of a team, in meeting strict timelines
- Excellent organisational skills with the ability to multi-task and work in an environment with shifting priorities
- Proactively seek to add value to processes, both existing and new
- Performance driven, with a 'can-do' attitude
- Proficiency in Microsoft Word, Excel, PowerPoint.
- Proficiency in an EU language (French/German/Spanish/Italian) would be an advantage
For further information on this Regulatory Affairs Executive position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / firstname.lastname@example.org
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