Regulatory Affairs Manager

Job Description

Title: Regulatory Affairs ManagerLocation: BerkshireTherapy Area: Unlicensed MedicinesSalary: Highly competitive salary + exceptional benefits on offerEvolve Consultant: Andy BoydRef: 7526We are currently looking to recruit a Regulatory Affairs Manager to join an exciting and growing Pharmaceutical organisation. The Regulatory Affairs Manager will conduct all associated regulatory activities for markets globally. The role will also contribute to the implementation, leading of projects and building of expertise within the Unlicensed Medicines space. This position reports directly to the Commercial Director. Based in the UK, there will be travel to Germany and the US officesRequirements:Life sciences or chemistry graduate to honours level or equivalentMaster’s degree, Post Graduate Diploma or PhD preferredRelevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)Previous experience in Regulatory Affairs (Human Medicinal Products)Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferredKnowledge of the global unlicensed medicines market and or the Pharmaceutical industry is preferredResponsibility examples:Contribute to Cross-functional Teams and Build Regulatory Expertise and provide regular updatesUtilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for unlicensed supply globally of products on behalf of clientsAttend relevant team and client meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessaryEnsure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activitiesProvide regulatory input to commercial strategic and operating planning processFacilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requestsUse knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customersAdvise on matters of compliance, regulatory requirements and regulatory policyPartner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reportsUtilise local knowledge of Regulatory authority’s expectations, ways of working etc to appropriately direct company strategy. Share updates with colleagues.Work with authorities if company position differs from authority position in order to obtain a better outcome for the business/patients as appropriatePopulate and Maintain Regulatory Databases. Responsible for database entry and the document management of regulatory transactions undertaken at local levelProduct Discontinuations: Liaise with internal and external client team/commercial/medical functions and advise on regulatory action required for discontinuation of a product in the country marketplaceRole Specific Competencies:Excellent communication skills with internal and external partnersAnalytical thinkingAbility to prioritise effectivelyResults focused with attention to detailAbility to multitaskExcellent written and verbal communication skillsAble to work on own and make decisions independently, where neededRecruitment Process:2/3 stage processIf you want to hear more about this role, please send us your CV by clicking apply now!