Regulatory Consultant
16 hours ago
Our client a boutique regulatory consultancy working with household names and start-ups in the life science sector provide a variety of consultancy services. This is a unique opportunity to join a business which is employee owned and share in the futuresuccess of the organisation whilst working on exciting projects across different territories.
The position can be based anywhere as remote working is on offer. The company operate sites in England and Scotland.
The Regulatory Consultant will be an active member of the Regulatory Affairs team and works alongside the Senior Management Team and Consultants in supporting regulatory projects and document writing activities.
**Responsibilities**:
- Support and lead regulatory projects, which may involve strategy, scientific advice or procedures relating to marketing authorisations.
- Preparation of documents to support regulatory activities at various stages of pharmaceutical or medical device development, including:
- Clinical Summaries and Overviews based on study and/or literature information
- Risk Management Plans
- Responses to Agency Requests
- Regulatory documents such as Scientific Advice briefing documents, PIPs, Orphan Designations
- SmPCs and package leaflet
- Investigators Brochures
- Clinical Evaluation Reports
- Educational materials for HCPs/clients, including training materials, slides, posters and presentations for conferences
- Ensuring that the content, format and structure of documents comply with regulatory, journal, or other guidelines
- Support activities of more junior regulatory and administration staff on specific projects
- Liaising with clients in collation, review and delivery of regulatory documentation
- Explore and develop new work opportunities for the business
- Develop and implement initiatives to train and strengthen the regulatory knowledge of the Team.
**Skills**:
- Regulatory and medical writing
- Ability to present complex information in a logical way
- Attention to detail
- Project-management mentality and a proven ability to meet deadlines
- Life Science experience in Regulatory or Medical Writing
- Ideally professional qualifications commensurate with the position
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales
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