Tuesday , October 20 2020

Holland and Barrett Careers – Senior Regulatory Affairs Associate

Website Holland and Barrett

Job Description:

The Regulatory Affairs team is responsible for legal compliance of all Holland & Barrett International’s Foods & Food Supplements, Cosmetics and Licensed Products (including Traditional Herbal Medicinal Products (THMPs) and Medical Devices). Reporting to the Senior Regulatory Affairs Manager, a vacancy has become available within the team for a Senior Regulatory Affairs Associate.

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.

Job Responsibilities:

  • Conduct a weekly literature search as part of pharmacovigilance duties
  • Communicating upcoming Regulation changes to the business and providing support and advice in dealing with impactful change
  • Liaising with UK, Ireland and The Netherlands authorities and submitting renewals for these regions
  • Partnering with Supplier Assurance, Production, Trading and other teams to support development of SOPs that will drive standardization and improvement across all aspects of the company
  • Investigating enquiries and challenges from regulatory authorities (MHRA, HPRA & MEB)
  • Support in the development of internal policies and standards
  • Writing PSUR’s
  • Review labelling (SPC, PIL and Labelling) for compliance against current pharmaceutical legislation
  • Support in GDP activities and inspections
  • Updating PSMF
  • Process incoming consumer adverse events (spontaneous reporting)
  • Review stability data
  • Maintaining THMP Marketing Authorizations by processing variations using eCTD
  • Approval of new product communications and creation of pack copy for own label artwork
  • Provision of regulatory advice to various departments within the business including the International team, Commercial teams and Web team
  • Review of marketing material and website content for legal compliance
  • Support NPD by provision of expert regulatory advice and guidance on new own label products and formulations
  • Act as the regulatory expert in Pharmacovigilance inspections

Job Requirements:

Qualification & Experience:

  • Ability to manage multiple priorities and to work to tight deadlines
  • Good organizational and interpersonal skills and excellent attention to detail
  • Highly motivated and proactive
  • Solid collaborative, consultative, problem solving and analytical skills

Job Details:

Company: Holland and Barrett

Vacancy Type:  Full Time

Job Location: Belfast, Northern Ireland, UK

Application Deadline: N/A

Apply Here