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Senior Regulatory Affairs Manager - Development

Business Type: Clinical Research Organisation
Job Type: Clinical Development, Clinical Study- Trials, CMC, Regulatory Affairs
Job Level: Not Specified
Position: Full Time
Salary: Competitive
Location: South East
Reference: 17863/001
Closing Date: 14/08/12

Our client, a specialist global pharmaceutical company and innovative leader in pharmaceutical and health care research and development, is mainly concerned with development activities. They are seeking a Senior Regulatory Affairs Manager for their Buckinghamshire location.

The Senior Regulatory Affairs Manager is responsible for the definition of regulatory strategy and subsequent implementation, in the European region (EU) and European economic Area (EEA). The Regulatory Affairs Manager will complete lifecycle management activities in line with legal/regulatory requirements and regional business needs.

Provide appropriate EU regulatory input to project teams
Plans and Implements regulatory activities in support of lifecycle management (renewals) and CMC maintenance in the region
Ensures effective planning, tracking, archiving of activities, especially submissions
Supports the communication of regulatory strategy in support of new product registration
Ensures that budgets and forecasts are developed and actuals managed in line with corporate requirements

Life Sciences Graduate and prior experience in product development functions
Knowledge of both European pharmaceutical regulations and guidelines and national regulations within the assigned region
Proven track record in CP, MRP and/or DCP
Extended Regulatory Affairs experience

Organisational and planning ability
Excellent negotiation skills
Excellent communication both written and verbal skills

BENEFITS OF THE ROLE: This leading pharmaceutical company is committed to fostering a friendly work place with no discrimination. They offer competitive annual salaries together with excellent benefits that include Pension Plan, Life Assurance, Private Medical Insurance, Disability & Accident Insurance, good Annual Leave, Performance related Bonus, Free Car Parking, Subsidised Restaurant, Sports & Social and more.

Fforde is acting as a recruitment agency/business.

KEY WORDS: Regulatory Affairs Manager, Development, Regulatory Strategy, Clinical Trials, Clinical Study, CMC, Life Science, Pharmaceutical, CP, MRP, DCP, CRO, Buckinghamshire

Posted: 17/07/2012 | NPJ Ref: 84205
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