Holland and Barrett Careers – Senior Regulatory Affairs Associate

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

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