Regulatory Affairs Consultant - Glasgow, United Kingdom - Real Staffing

Real Staffing

Verified Company

Glasgow, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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
Projectmanagement 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