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Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer, Hertfordshire, EU, Harlow, Submissions

Your new company
Have you got experience in European Regulatory Affairs, with a Life Science or similar degree? Would you like to work in the varied and fast-paced environment of licensed-in generic products? If so, we're looking for someone like you...
My client is a leader in Global Healthcare, in a line of generic and speciality treatments backed by Global development and manufacturing capabilities. They are ranked top 10 Pharmaceutical companies in the world, with Cutting edge Research and development and uncompromising quality. Active in 80 countries with approximately 57,000 employees. This company is recruiting for a senior artwork planner on a fixed term contract of one year with scope for extension.

Your new role

  • Review the technical content of third party dossiers as part of the in-licensing decision making process
  • Work closely with third party partners in order to prepare and submit high quality regulatory dossiers including Marketing Authorisation Applications, response to Health Authority questions and critical pre-launch post-approval variations
  • Be able to understand complex issues and clearly communicate issues to customer base
  • Represent team during strategic and technical discussions, including participating in project teams
  • Enjoy the challenge of working under pressure whilst consistently ensuring that internal and external deadlines are met
  • Line management of a Regulatory Affairs Associate may be part of the role, for the right candidate

What you'll need to succeed
  • Degree (or equivalent) in Pharmacy/Chemistry or Life Sciences related subject
  • Substantial industrial experience within Regulatory Affairs including practical experience of European MRP/DCP submission procedures
  • A good understanding of European regulatory requirements and guidelines for generic products.
  • Previous CMC experience (or a demonstrated technical aptitude) and familiarity with the scientific content of the dossier
  • Previous supervisory or mentoring experience may be an advantage

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.


Job Type:
Life Sciences
£35,000 - £45,000
Apply Now

Talk to a Consultant

Talk to Jack Lund, the specialist consultant managing this position, located in London City

107 Cheapside, London, EC2V 6DN

Telephone: 02034650033

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