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 247jobseeker.com
