job details for:
Regulatory Affairs - Regulatory Affairs Manager Jobs - Europe

Regulatory Affairs - Regulatory Affairs Manager Jobs - Europe (Job Ref: WR/JOBS/20888-7965)

Job Description :

Flame Pharma - Regulatory Affairs - Regulatory Affairs Manager Job - Europe

Would you like the opportunity to demonstrate your knowledge and expertise within regulatory affairs with one of the largest companies in the pharmaceutical services sector? An exciting opportunity has arisen for a talented and skilled Regulatory Affairs Manager. If you are looking for a positive 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.

Key Responsibilities

• 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 

Key Requirements

• 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 Brussels.

For further information and to apply for this vacancy, please contact Flame Pharma on 0800 085 0858