Regulatory Affairs Consultant

2 months ago

Glasgow, United Kingdom Real Staffing Full time

Our client are a boutique Regulatory Consultancy based in Scotland with staff operating out of that site and also working remotely around the UK. They partner marquee names in the life science sector delivering Regulatory Affairs projects.

They are looking to add a Regulatory Consultant to the team to help deliver Regulatory Affairs work and also share in the future success of this employee owned company.

The Regulatory Consultant will be an active member of the Regulatory Affairs team and work alongside Senior Management and Consultants in supporting regulatory projects.

**Role**:
The Regulatory Consultant will be responsible for:

- Supporting and leading regulatory affairs 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 and/or medical device development, including:

- Clinical Summaries and Overviews based on study and/or literature information
- Risk Management Plans
- Responses to Agency Requests
- Scientific Advice briefing documents, e.g. PIPs, Orphan Designations etc.
- 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 their documents comply with regulatory, journal, or other guidelines

Working with the team and external consultants to:

- Support activities of more junior regulatory and administration staff on specific projects
- Liaising with clients in collation, review and delivery of regulatory documentation

Working with the Board to help:

- Explore and develop new work opportunities for the business
- Develop and implement initiatives to train and strengthen the regulatory knowledge of the Team.

**Skills**:

- Ideally Life Sciences qualifications or equivalent practical experience in a similar role
- Communication in various written formats and face to face
- Ability to present information
- Project-management skills and ability to meet deadlines

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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