Regulatory Affairs Manager in London - Takeda

Job Overview

London, England
Job Type
Full Time
Date Posted
3 days ago

Additional Details

Job ID
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Job Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionThe Regulatory Affairs Manager is responsible for managing the resources, personnel and responsibilities of the UK and Ireland Regulatory Affairs Department with respect to defined therapy areas, in order to:Manage the regulatory team to ensure consistent and effective performance, with technical on the job support where needed.Ensure that the necessary regulatory support is provided to local, regional and global regulatory affairs functions and collaborates fully with other local and global functions including commercial teams.Maintain existing, and obtain new, Marketing Authorisation’s in UK and Ireland for national, EU converted GB, MRP, DCP and Centralised products in support of Takeda’s commercial activities, ensuring conformance to national and EU Drug Laws.Ensure regulatory risks are appropriately anticipated, communicated and mitigated.Advise on and implement regulatory strategies and deliverables for licensed and development products in the UK and Ireland.Keep up to date with pharmaceutical legislation and guidelines in the UK, Ireland and the EU and advising the business, especially in relation to evolving UK registration pathways and informing the Takeda business.Gain and maintain familiarity with the Takeda UK and Ireland product ranges for which you are responsible.Ensure quality standards are consistently met and submissions are made according to the agreed deadline.Assist the Head of Regulatory Affairs with developing strategies to optimize the efficient running of the department.Identify issues which may impact on project timelines.ResponsibilitiesPersonnel Management:Manage the workload and personal development of your team to  ensure consistent and effective performance, with technical on the job support where needed.Supervise and mentor other regulatory staff as required by the Head of Regulatory AffairsImplement development plans for all team members, and provide evidence of adherence.Conduct mid-year and annual performance reviews, and address any identified performance issues as required.Promptly notify management of any changes in resource requirements and ensure progression planning.Regulatory Affairs:Advise on and implement regulatory strategies and deliverables for licensed products in the UK and Ireland.Advise on and implement regulatory strategies for obtaining optimal regulatory approvals in the UK for Takeda’s development product portfolio to support Takeda’s commercial goals, including providing expert opinion on the likelihood of success for submissions and approvals, taking into account evolving UK registration pathways.Keep abreast of pharmaceutical legislation and guidelines in the UK, Ireland and the EU and update the business appropriately, especially in relation to evolving UK registration pathways and informing the Takeda business.Prepare, compile and submit a range of regulatory applications for licensed products, including:In cooperation with Global Regulatory Affairs, assist in the compilation of new Marketing Authorisation ApplicationsType I and Type II variationsArticle 61(3) Leaflet and labelling changesChange of ownership applicationsRenewalsPSURsPrepare updated product information texts, ensuring they are clear and accurate, for submission with various regulatory applicationsEnsure internal approval of updated product information by appropriately qualified medical personnel and arrange timely implementation following approvalWork with the Artwork Coordinators to create/update/submit and implement approved artwork mock-ups via the Electronic Artwork Management SystemLiaise with the Medical Information department to arrange upload of approved product information to the eMC and medicines.ieEnsure that any regulatory commitments or requests for information are logged appropriately and responded to by the agreed deadline, and answer routine correspondences on own initiativeLiaise with the Pharmacovigilance department to ensure that any additional Risk Minimisation Measures required for a product are implemented (for example additional follow-up)For products where Educational/Risk Minimisation Materials are required, prepare, submit and implement the materials in cooperation with LOC Pharmacovigilance, ensuring that relevant personnel are briefed on their use and purpose, and that data is being recorded in relation to their effectiveness if requiredEnsure accurate regulatory records are kept.  This includes:maintaining and updating the electronic regulatory tracking databasemaintaining and updating the electronic  document management systeminputting and retrieving information from the electronic quality management system as requiredensuring the paper and electronic filing is kept up to datemaintaining the UK and Ireland product listmanagement of the external archiving of regulatory documentationFor products with whom Takeda have a co-licensing or out-licensing arrangement with a third party, liaise with the third party to ensure regulatory compliance is maintainedAct as regulatory contact point for local, international and global teams on UK/Irish regulatory mattersManage direct interactions with local UK/IE regulatory authorities for relevant national, MRP/DCP, EU Centralised and EU converted GB licensesFacilitate interactions by the European or Global regulatory personnel where Ireland is the rapporteur/co-rapporteur or where Scientific Advice is sought in UK or IrelandProvide input to local cross functional teams on status of planned and approved regulatory submissionsEnsure, in conjunction with Head of Regulatory Affairs, that regulatory requirements of UK & Ireland are fully represented in discussions at Global, Regional and Local levelsBuild good relationships with internal and external stakeholders, particularly within Global Regulatory Affairs and at the Regulatory AuthoritiesOther duties as required:Review reports received by Global Regulatory Affairs (GRA) in relation to data required for the Pharmacovigilance System Master File (PSMF) promptly and thoroughly and work with GRA to resolve any errors or discrepanciesSupport with periodic requests (e.g. tender support, HTA submissions, shortage notifications, unlicensed medicines requests, PSMF reviews)Provide regular updates to the Head of Regulatory Affairs regarding the activities completed/projects planned and contribute to the monthly Medical Meetings/EUCAN LOC RA meetingsProvide launch readiness and other commercial project team supportMonitor the status of competitor Marketing Authorisation’s as agreed with the local businessArrange payment of fees to the Healthcare Products Regulatory Agency (HPRA) and payment of invoices from the Medicines and Healthcare Products Regulatory Agency (MHRA) and European Medicines Agency, utilising the Takeda electronic invoicing and purchase order systemsAttend and participate in local and global meetings/calls as required, and present on regulatory topics when requestedReview and update Regulatory Standard Operating Procedures (SOPs) to ensure they comply with UK and Irish regulatory legislation and with Global Quality principles, standards, policies and SOPsActively seek to minimise risks to the business, managing risks identified and alerting the Head of Regulatory AffairsAny other associated dutiesEducation, Experience, Skills/Competencies and DispositionQualifications:Required:Educated to at least degree level in a scientific disciplineKnowledge of national, EU converted GB, MRP, DCP & Centralised procedures in the UK and IrelandGood knowledge of the development process for medicinesDesired:Management qualificationsExperience:Required: At least 8 years’ experience within a regulatory affairs role within the pharmaceutical industryProven record of success in managing a small to medium sized team and supervising staff with various levels of knowledge and expertiseCapable of critically reviewing and integrating scientific information from a variety of disciplinesExperience of managing multiple complex projects at the same time Experience of working across cultures and in a busy, complex, matrixed environment Experience of preparing and submitting post-marketing regulatory applications to the MHRA and HPRA (i.e. variations, renewals, post-marketing commitment submissions, PSURs and other ad hoc activities as required) Experience of developing strategy for new Marketing Authorisation applications Experience of writing and updating comprehensible, clear, product information documents, including development of labelling and leaflet artworks. Keeping up to date with Regulatory intelligence and sharing accordingly. Contributing regulatory input to product strategy discussions. Experience of producing written regulatory communications with clarity, accuracy and rigor.Experience of seeking Scientific Advice and liaising with the regulatory authorities over new products/new indications/line extensionsExperience of working within electronic regulatory tracking databases and document management systems.Desired:Experience of working within a team that successfully registered and launched a new ethical product in the EU.Skills/CompetenciesRequired:Ability to work under pressureSelf-motivated and ability to use initiative to resolve problemsSolution drive styleExcellent organizational, planning and time management skillsComputer literate, including Adobe Acrobat and Microsoft ExcelEffective communicator both written and verbalStrong Interpersonal skillsExcellent attention to detailAbility to work independentlyAnalytical skillsNegotiation skillsCan effectively prioritise and manage multiple competing tasks and demandsDesired:Demon


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