Senior Regulatory Affairs - Pharma / GMP ( Perm )

Job Title: Senior Regulatory Affairs - Pharma / GMP ( Perm )
Contract Type: Permanent
Location: Wembley, London
Salary: Bonus
Start Date: ASAP
Reference: J905197_1584008811
Contact Name: Ben George
Contact Email:
Job Published: March 12, 2020 10:26

Job Description

Role: Senior Regulatory Executive (Pharma)

Location: Wembley

Salary: Highly Competitive

Russell Taylor Group has a fantastic opportunity for a Regulatory Affairs Expert to join a Pharmaceutical manufacturing company based Wembley area. You will have a solid history of working within a pharmaceutical company and a solid background in Regulatory Affairs and the MHRA.


  • Assist in the preparation and review of dossiers for MA applications (DCP, MR or national) and ensure timely submission of applications.
  • Assist in the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory submissions (DCP, MR or national) and ensure timely submission of applications
  • Assist in the preparation and review of responses to requests for further information from regulatory authorities
  • Prepare or review of national submission packages after the close of procedures
  • Liaise with regulatory authorities when required
  • Maintaining the product life cycle once the licence is approved.
  • Responsible for the product approval package review and maintenance.
  • Review of product information before product launch.
  • Liaising with internal and external contacts to ensure that dossiers are prepared following the current best practice standards.
  • To support the Regulatory Manager with SOPs, Change controls and review of internal processes.
  • Keeping up-to-date with the current regulations/ guidelines and share the knowledge with the team.


  • Collaborate with internal departments for resolving any regulatory discrepancies.
  • Creating and monitoring internal quality and non-quality changes through change control system.
  • Proactively troubleshooting technical/quality issues relating to product preparations and submissions.
  • To liaise with CROs to ensure clinical trials are conducted in accordance with the regulatory requirements.
  • Liaise with contract manufacturers when required
  • Providing regulatory support to the other departments
  • Follow up with regulatory authorities on submissions and regulatory issues.
  • Training of junior members of the Regulatory Department
  • Involvement in review of third party dossiers when required


  • Degree in life science subject with good knowledge of medicines and how they are used
  • Well-developed regulatory experience in the pharmaceutical industry.
  • Understanding of the drug development process.
  • Good knowledge of EU directives, ICH guidelines.
  • Ability to prepare high quality regulatory dossiers
  • Ability to communicate effectively with regulatory authorities and other departments.
  • Ability to handle multiple tasks in a fast-paced and constantly changing environment

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