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Regulatory Affairs - Regulatory Affairs Manager Jobs - Cambridgeshire

Regulatory Affairs - Regulatory Affairs Manager Jobs - Cambridgeshire (Job Ref: WR/JOBS/19108-7079)

Job Description :

Job Summary

Regulatory Affairs - Regulatory Affairs Manager Job - Cambridgeshire

An opportunity to work with one of the largest companies in the pharmaceutical services sector has arisen for a talented and skilled Regulatory Affairs Manager.

If you are looking for a challenge and to accelerate your reg affairs career by working on multiple projects for world leading clients, then this position is for you.

Job Title 

Regulatory Affairs Manager

Background

Due to expansion, our client is looking to recruit a Regulatory affairs manager, to provide regulatory advice on strategy and manage projects in the provision of regulatory affairs services.

Qualifications & Experience 

• To provide project specific regulatory services and co-ordination of projects
• To provide regulatory strategy and product development advice to internal and external clients
• To manage other regulatory affairs individuals as appropriate
• To assist in business development and pricing of projects for Regulatory Affairs in the company
• To review and prepare regulatory submissions in Europe, South Africa and Pacific Rim 
• To provide regulatory advisory and training service for regulatory affairs in the company
• To lead and train a small group of regulatory professionals and/or regulatory consultants as appropriate
• To assist in budgeting
• Other duties as required
• General advice and management of other regulatory affairs professionals and outside consultants as necessary
• Guidance and management of the Senior Regulatory Affairs Secretary

Qualifications and Experience

• Degree in Pharmacy or Life Sciences, a higher qualification in a relevant subject
• Post-graduate courses in Regulatory Affairs would be an advantage
• Experience in a broad range of Regulatory Affairs projects
• Good knowledge of Regulatory Affairs in Europe especially the UK
• And or European clinical trials procedures
• Previous managerial or supervisory skills would also be an advantage
• Good interpersonal skills are essential
• Good knowledge of the European Regulatory Affairs Procedures
• Proven ability to work effectively in a team
• A good knowledge of the UK CTX procedure and application
• Familiar with computers and their applications
• Good organisational and planning skills
• Must be able to work on own initiative
• Able to plan work at least several months ahead
• Able to manage and plan projects and other people
• Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention to detail, multiple project tasking

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary from £40,000 (negotiable).

Key Words 

Regulatory affairs,Regulatory affairs manager, Reg affairs, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in Cambridge.

For further information on this vacancy, please contact Flame Pharma.