job details for:
Regulatory Affairs - Regulatory Affairs Manager - Cambridge Area,

Regulatory Affairs - Regulatory Affairs Manager - Cambridge Area, (Job Ref: WR/JOBS/29140-15708)

Job Description :

Flame Pharma Regulatory Affairs - Regulatory Affairs Manager - Cambridge Area,

Working for a leading Clinical Development company, the Regulatory Affairs Manager will provide regulatory advice and carry out projects in the provision of regulatory affairs services. You will liaise with internal and external clients in the provision and marketing of these services. 

The Regulatory Affairs Manager will offer general advice and management of other regulatory affairs professionals, assistants and outside consultants as necessary, with line management responsibility for Senior/Regulatory Affairs Executives and Associates as necessary by business need

The Role

The Regulatory Affairs Manager will provide project specific regulatory services and co-ordination of projects, providing regulatory strategy and product development advice to internal and external clients.

You will manage other regulatory affairs individuals as appropriate, and assist in business development and pricing of projects for Regulatory Affairs in the company. The Regulatory Affairs Manager will review and prepare regulatory submissions in EMEA & Asia Pacific and 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.

The Person

• Broad regulatory affairs experience. 
• Good interpersonal skills are essential. 
• Good knowledge of the European Regulatory Affairs Procedures. 
• Proven ability to work effectively in a team. 
• Good knowledge of the European/ROW Regulatory Affairs Procedures for Clinical Trial Authorisation and Marketing Authorisations.
• Expert knowledge of ICH and regulatory guidelines in Europe/ROW

Key Words

Regulatory Affairs, CRO, Regulatory Affairs Manager, Manager, CMC, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Job, Recruitment, UK, Cambridge, Europe

 For more information please apply for this position or alternatively call Flame Pharma on 0800 0850858