Our client, a world leading pharmaceutical company, discovers, develops, manufactures and markets a wide range of innovative, value-added pharmaceutical products for both humans and animals around the world. They are currently seeking an Emerging Markets Regulatory Contractor for to cover maternity leave for a 11 month contract at either their sites in Kent or Berkshire.
The job role for this position is to create the CMC sections of Emerging Market initial submissions for established and/or new products as well as responding to CMC-related questions as part of the project team. There will be further regulatory activities as required.
The Regulatory Contractor will be required to use establish systems and in particular the web-based document management systems to ensure global transparency of submitted and approved documentation.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Life sciences degree.
Regulatory Affairs experience in European and/or global market primary applications or similar would be beneficial
Understanding of European legislation and both technical and procedural guidance
PERSONAL SKILLS & ATTRIBUTES:
Good IT skills
Strong communications skill
Good negotiation skills
Excellent team player
BENEFITS OF THE ROLE: This Company that has been consistently recognised as one of the nation''s best employers offers state of the art R&D facilities and workplaces that have been designed to meet their employees'' needs with flexible hours, childcare centres, health and fitness facilities and sports and recreational opportunities. You can be assured of a competitive remuneration together with comprehensive and customised benefits and competitive, performance-based compensation.
Fforde is acting as a recruitment agency/business.
KEY WORDS: Emerging Markets, Regulatory, Regulatory Affairs, CMC, Project Management, Clinical Research, Clinical Trials, Science, Pharmaceutical, CRO, Kent, Berkshire, UK