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 Regulatory Manager for their Buckinghamshire location.
The Regulatory Manager will support the implementation of regulatory operational activities in the UK/Ireland, and provides regulatory support to the registration and post-licensing of EU medicinal products in the UK/Ireland region. They will be responsible for the maintenance of regulatory packaging, tracking systems and regulatory knowledge databases for the UK/Ireland and support the implementation of regulatory strategy in Europe and the EEA and provides regulatory support for the registration and post-licensing activities of medicinal products.
PRINCIPAL RESPONSIBILITIES include:
Review and approve product-related packaging and other materials, as required
Plan and implement regulatory activities in support of lifecycle management and CMC maintenance in the region
Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during lifecycle management and maintenance
Manage marketed product labelling
Implement CMC changes in line with agreed company change control and global CMC plans
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Life Sciences Graduate and prior experience in product development functions
Good knowledge of both national regulations within the UK/Ireland region and European pharmaceutical regulations and guidelines
Regulatory Affairs experience
Conversant with the primary functions of pharmaceutical development, microbiology, toxicology, clinical research and quality assurance
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 Manager, Regulatory Strategy, Lifecycle Management, License Maintenance, Regulatory Affairs, Renewals, Variations, Registration, Clinical Trials, CMC, Pharmaceutical, CP, MRP, DCP, Buckinghamshire
Posted: 17/07/2012 | NPJ Ref: 84206