Senior Regulatory Affairs Executive- Pharmaceutical

Job Title: Senior Regulatory Affairs Executive- Pharmaceutical
Contract Type: Permanent
Location: Wembley, London
Salary: Up to £0.00 per annum
Reference: J905602_1594301180
Contact Name: Hannah Williams
Contact Email:
Job Published: July 09, 2020 14:26

Job Description

Senior Regulatory Executive, Pharmaceutical **PRE & POST APPROVAL SUBMISSIONS **

Location: Wembley (some remote days could be arranged/ agreed)

Type: Permanent

Salary: Up to £54,000 DOE

Additional: Company bonus scheme, Healthcare Plan, Life Assurance, Pension, Parking onsite

Our Client, a leading Pharmaceutical manufacturing and Pharmaceutical distributor are looking to recruit for an experience Senior Regulatory Executive (SRE) to work at their modern site near to Watford; the SRE will play a vital role in the preparation and submission of documentation, as well as management of the regulatory function/s.

Reporting to the RA Manager:

  • Assisting in the preparation and review of dossiers for applications and ensure timely submission of the applications.
  • Assisting in the preparation and review of dossiers for variation applications, renewals and other regulatory submissions (DCP, MR or national) and ensure the timely submission of applications
  • Assisting in the preparation and review of response/s to requests for further information from regulatory authorities
  • Preparing or reviewing of national submission packages after the close of procedures
  • Liaising with regulatory authorities when required
  • Maintaining the product life cycle once the licence is approved
  • Responsible for the product approval package review and maintenance
  • Reviewing of product information before the launch
  • Liaising with internal and external contacts to ensure that dossiers are prepared following the current best practice standards
  • Supporting 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.
  • Collaborating with internal departments and resolving any regulatory discrepancies
  • Creating and monitoring internal quality and non-quality changes through change control system/s
  • Troubleshooting technical/quality issues relating to product preparations and submissions
  • Liaising with CROs to ensure clinical trials are conducted in accordance with the regulatory requirements
  • Liaising 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

The Person:

  • Will hold a Degree in a relevant - Life Sciences or related subject
  • Experience in both pre & post submission experience (ESSENTIAL)
  • Solid management experience in an RA role; within an Pharmaceutical - GMP setting
  • Someone with experience dealing with EU, US, Canada and Middle East territories within RA
  • Good knowledge of EU directives, ICH guidelines
  • Strong leadership skills

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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