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Regulatory Affairs Executive - Cambridgeshire



Business Type: Clinical Research Organisation
Job Type: Regulatory Affairs
Job Level: Not Specified
Position: Full Time
Salary: Competitive
Location: UK - East Anglia
Reference: 17746/002
Closing Date: 02/08/12
Background:
Our Client is an expert Regulatory, Clinical Research and Quality Services consultancy to the healthcare industry worldwide, who focus is on the planning and execution of product development programmes, including a full range of regulatory support services and the management and monitoring of early phase clinical trials. They are currently seeking a Regulatory Affairs Executive for their Cambridgeshire office.

JOB ROLE:
The Regulatory Affairs Executive will provide regulatory services internal and external clients, including preparation, review, submission and project management of regulatory applications.

PRINCIPAL RESPONSIBILITIES include:
Provide up to date regulatory advice to internal and external clients as required
Prepare, review, submit and project manage regulatory submissions in compliance with the applicable GFA SOPs, regulatory guidelines and legislation
Attend client project meetings as required
Maintain electronic and hard copy project and regulatory files
Participate in business development activities as required
Provide input into monthly invoicing

QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Degree in Life Sciences
Understanding of the drug development process
Experience of the development of biopharmaceuticals (eg vaccines, cell & gene therapies and monoclonal antibodies) would be an advantage

PERSOAL SKILLS & ATTRIBUTES:
Strong communication & interpersonal skills
Good IT skills

KEY WORDS: Regulatory Affairs, Clinical Research, Drug Safety, Drug Development, Clinical Study, Clinical Trials, GFA, Life Sciences, Biopharmaceuticals, Pharmaceutical, Cambridgeshire

Posted: 05/07/2012 | NPJ Ref: 83753
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