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PharmaLex has created this exciting, new opportunity for an experienced regulatory affairs professional to join our growing team in the UK.

PharmaLex is one of the largest providers of development consulting, regulatory affairs, quality management & compliance and pharmacovigilance services worldwide. Our global teams of experts lead clients through early stage strategic planning activities, non-clinical requirements and clinical development, regulatory submission processes and finally guide them to market approval, after which our support extends into product maintenance activities. As a global organisation with over 31 offices in 17 countries, our reputation, client-base and international footprint continue to grow, making it a very exciting time to join PharmaLex. With excellent local and international collaboration, the associated project work is diverse and rewarding.

 

Senior Manager Regulatory Affairs


Your Job

  • Ensuring that regulatory affairs, development consulting and scientific affairs programmes and projects are delivered to our high standards
  • Providing regulatory expertise to regulatory programmes and projects being managed by PharmaLex UK and other international offices
  • Professional interaction with regulatory authorities
  • Technical support to business development
  • Ensuring that clients’ budgetary expectations are appropriately managed
  • Accurate time reporting.

     

Your Profile

  • The successful candidate will need to demonstrate the experience and skills to build on our strong reputation for excellence in pharmaceutical regulatory affairs, development consulting and scientific affairs.
  • Candidates should be experienced to at least manager level and bring sound experience in devising and implementing successful regulatory strategies for MAAs and/or post-authorisation procedures, and have extensive procedural management experience.
  • You should have the aptitude to take on defined roles in managing regulatory programmes for product portfolios. EU regulatory experience, first-class communication skills and a diplomatic, client-orientated manner are essential.
  • Regulatory affairs experience supporting other regions, a background in regulatory CMC and/or experience with medical devices or cosmetics would be an advantage. The minimum qualification is a degree in a relevant scientific discipline.
  • Given the nature of the role, some UK and international travel can be expected.
 

We offer you

  • The position can be based in our office in Bourne End, in the heart of the Thames Valley, or in our office in Cornwall, one the most beautiful counties in the UK
  • Diversified and challenging job
  • Flexible working hours



To apply, please provide your CV and a covering letter, explaining how you meet or exceed the specifications for this position, any visa requirements and your salary expectations.

Agencies only by prior agreement for the specific job opportunity.


 


If you are interested to join our PharmaLex team taking over this challenging job opportunity in our future-oriented company, we look forward to receiving your application documents stating your earliest possible starting date and salary expectations online.

For further information please don’t hesitate to contact us:

Ms Laura Escabias
Senior European Recruitment Specialist


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