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.
PRINCIPAL RESPONSIBILITIES include:
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
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
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
PERSONAL SKILLS & ATTRIBUTES:
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