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Global Regulatory Affairs Manager

3 months ago

Hertfordshire, Eastern England, United Kingdom PrimeRA Pharma Partners Full time

The Role

PrimeRA Pharma Partners are looking to hire a full time, hands on, regulatory affairs professional who can drive key regulatory document preparation for cell and gene therapy projects, including but not limited to scientific advice/regulatory authority meetings, orphan designations, paediatric plans, clinical trial applications and MAA/BLA sections, as well as be a key resource for the Partners to enable our clients to be successful.


Key Accountabilities

  • Drafting of regulatory documentation for regulatory procedures in the EU, UK and US
  • Monitoring the regulatory environment to provide key intelligence and thoughtful insights for active projects
  • Be a super-user in compiling and submitting regulatory applications throughout the clinical and commercial lifecycle


Key Experiences

  • Demonstrated career progression to date
  • Contributed to at least one scientific advice procedure
  • Contributed to at least one MAA or BLA process
  • Demonstratable experience communicating with, or interpreting, direct communications from regulatory agencies in Europe and/or US
  • Working knowledge of latest EU/US/ICH guidelines and pharmacopoeia monographs


Key Personal Attributes

  • Self-motivated
  • Critical eye for detail
  • Exceptional time management skills
  • Takes pride in the work they are delivering and the success of others
  • Goes the extra mile


Role can be located anywhere in the UK, working remotely, with occasional in-person meetings as needed. National and international travel may be required depending on client projects.


No applications will be accepted from recruitment firms at this time