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Senior Regulatory Affairs Associate Licenced Products

Job LocationNuneaton
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-timeB

Job Description

The RoleThe Regulatory Affairs team is responsible for legal compliance of all Holland & Barrett Internationals Foods & Food Supplements, Cosmetics and Licenced Products (including Traditional Herbal Medicinal Products (THMPs) and Medical Devices). Reporting tothe Senior Regulatory Affairs Manager for VHMS, THRs and International (VITs), a vacancy has become available within the team for a Senior Regulatory Affairs Associate (Licenced Products).The role will suit a graduate in Chemistry, Bioscience, or a closely related scientific field; alternatively qualified in regulation related to Medicines. Additional skills are welcomed.Main Responsibilities:

  • Support NPD by provision of expert regulatory advice and guidance on new own label products and formulations
  • Approval of new product communications and creation of pack copy for own label artwork
  • Review of marketing material and website content for legal compliance
  • Communicating upcoming Regulation changes to the business and providing support and advice in dealing with impactful change
  • Maintaining THMP Marketing Authorisations by processing variations using eCTD
  • Liaising with UK, Ireland and The Netherlands authorities and submitting renewals for these regions
  • Investigating enquiries and challenges from regulatory authorities (MHRA, HPRA & MEB)
  • Review labelling (SPC, PIL and Labelling) for compliance against current pharmaceutical legislation
  • Review stability data
  • Conduct a weekly literature search as part of pharmacovigilance duties
  • Writing PSURs
  • Updating PSMF
  • Process incoming consumer adverse events (spontaneous reporting)
  • Act as the regulatory expert in Pharmacovigilance inspections
  • Support in GDP activities and inspections
  • Provision of regulatory advice to various departments within the business including the International team, Commercial teams and Web team
  • Support in the development of internal policies and standards
  • Partnering with Supplier Assurance, Production, Trading and other teams to support development of
  • SOPs that will drive standardisation and improvement across all aspects of the company
The Person
  • Good organisational and interpersonal skills and excellent attention to detail
  • Highly motivated and proactive
  • Solid collaborative, consultative, problem solving and analytical skills
  • Ability to manage multiple priorities and to work to tight deadlines
  • Knowledge of food supplements legislation is preferred, but not essential

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