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Senior Regulatory/ Regulatory Affairs Officer

Job Title: Senior Regulatory/ Regulatory Affairs Officer
Contract Type: Permanent
Location: Widnes, Cheshire
Industry:
Salary: £26000 - £30000 per annum
Reference: J912743_1647359635
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: March 15, 2022 15:53

Job Description

Senior Regulatory/ Regulatory Affairs Officer

Location: Widnes

Hours: 8:00 - 16:30 Monday to Friday, ONSITE.

Salary: Upto £30,000

Russell Taylor is working exclusively with a well-known 'generics' - Pharmaceutical manufacturer based in Widnes and part of a wider/ national consortium. They are looking to appoint a Senior RA Officer or someone who is wanting to step up into a more senior RA role from being an RA Assistant.

The role:

  • To maintain marketing authorisation compliance via life cycle management of existing licences and maintaining awareness of new regulatory legislations
  • To submit MAA, Piggy-back and Site Transfer variations to support the NPD pipeline
  • Author and review Regulatory SOP's
  • Submit sunset clause applications, change of ownership applications, and licence renewals as required
  • Manage artworks using the ProcEdge system
  • Complete and manage closure of Regulatory change controls
  • Maintain Technical Summaries for all licenced products
  • Liaise with external regulatory agencies to facilitate variation approvals
  • Build strong relationships with customers and members of other departments
  • Ensure Safety variations are submitted within PV timelines
  • Ensure Regulatory approvals are communicated to the relevant departments within specified timelines

The Person:

  • Previous RA experience in an GMP /MHRA - Pharmaceutical setting is essential for this role.
  • Experience/d in artwork approval/s and submissions.
  • Able to demonstrate strong written and verbal English.

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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