Specialists in Pharma, Clinical & IT Recruitment

Regulatory Affairs

 

The Regulatory Affairs industry consists of professionals who are fundamental in the processing of drugs from manufacturing to marketing. Their core responsibility is the timely preparation and submission of crucial documentation through to the relative governing bodies, including the MHRA, FDA and EMA. They are also key in the liaison between company and the Health Authority offering guidance and expertise when taking a product from site to market.

We focus in the areas of:

  • Chemical Manufacturing Control (CMC)
  • Generics (Variations, Renewals)
  • MRP (Mutual Recognition Procedure)
  • DCP (Decentralised Procedure)
  • Clinical Trial Applications (IMPD, IND, NDA)
  • MAA (Marketing Authorisation Applications)
  • Medical Devices (MDD, ISO)
  • PIL, SmPC and Labelling

We cover the following roles:

  • Regulatory Affairs Officer / Associate
  • Regulatory Manager / Specialist
  • Regulatory Senior Manager
  • Director of Regulatory Affairs
  • Head of Regulatory
  • VP of Regulatory

 

Twitter