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Senior regulatory affairs officer

Scantec Personnel
Job LocationAltrincham
EducationNot Mentioned
Salary37,000 - 51,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Senior regulatory affairs officerFull Time Permanent WFH Option Manchester, Stockport, Oldham, Rochdale, Hyde, Salford, Lancashire.A leading Pharmaceutical Manufacturing company is currently recruiting a Senior regulatory affairs officer reporting into the Regulatory affairs director.This role would suit someone looking to take the next step in developing their career by immersing themselves into a friendly and supportive workspace with the abundance or new skills and experience.Duties:

  • Contribute to the development and monitoring of regulatory strategies for new and existing products
  • Contribute to establishment and implementation of regulatory strategic and tactical plans
  • Update product information (SmPC and Labelling) in line with current EU guidelines/requirements (e.g. excipient warnings, QRD etc.)
  • Prepare, review, publish and submit responses to authority questions
  • Record and maintain licence particulars (Name, MA Number, Active, Manufacturer, ATC code, Excipient List, etc.) on Regulatory Information Management System
  • General administrative duties pertinent to the function of the department
Qualifications and Experience:
  • Life Sciences Degree
  • At least 5 years of relevant Regulatory Affairs experience
  • Excellent working knowledge of CMC (Module 3) and of regulatory dossier in general
  • Knowledge and familiarisation with current UK and EU regulatory legislation/guidelines/requirements and ability to apply those strategically and tactically to new registrations and post approval submissions
  • Knowledge and familiarisation with FDA guidelines and ANDA registration process preferred
  • Experience in marketing authorisation applications and post-approval activities and submissions
  • Ability to swiftly locate, digest and use information from primary online sources (e.g. EMA, CMDh, EDQM, MHRA, FDA)
  • Regulatory advice to support UK and EU strategies
  • Ability to work autonomously or as part of a team
  • High organisational skills and time management
  • Ability to manage multiple tasks in balance
  • Excellent IT skills
Please contact for discuss further. Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis. Agency PAYE, Umbrella and CIS (if applicable) engagementmodels are also available, which will result in a different pay rate than advertised above.Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you dont hear from us within 28 days your application has not been shortlisted atthis time, to be considered for future vacancies please register with us on our website.

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