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Regulatory Affairs Manager

応募後で応募 求人ID R0053868 掲載日 02/02/2022 Location:London, United Kingdom

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Job Description

The 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.

Responsibilities

Personnel 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 Affairs

  • Implement 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 Applications

    • Type I and Type II variations

    • Article 61(3) Leaflet and labelling changes

    • Change of ownership applications

    • Renewals

    • PSURs

  • Prepare updated product information texts, ensuring they are clear and accurate, for submission with various regulatory applications

  • Ensure internal approval of updated product information by appropriately qualified medical personnel and arrange timely implementation following approval

  • Work with the Artwork Coordinators to create/update/submit and implement approved artwork mock-ups via the Electronic Artwork Management System

  • Liaise with the Medical Information department to arrange upload of approved product information to the eMC and medicines.ie

  • Ensure that any regulatory commitments or requests for information are logged appropriately and responded to by the agreed deadline, and answer routine correspondences on own initiative

  • Liaise 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 required

  • Ensure accurate regulatory records are kept.  This includes:

    • maintaining and updating the electronic regulatory tracking database

    • maintaining and updating the electronic  document management system

    • inputting and retrieving information from the electronic quality management system as required

    • ensuring the paper and electronic filing is kept up to date

    • maintaining the UK and Ireland product list

    • management of the external archiving of regulatory documentation

  • For 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 maintained

  • Act as regulatory contact point for local, international and global teams on UK/Irish regulatory matters

  • Manage direct interactions with local UK/IE regulatory authorities for relevant national, MRP/DCP, EU Centralised and EU converted GB licenses

  • Facilitate interactions by the European or Global regulatory personnel where Ireland is the rapporteur/co-rapporteur or where Scientific Advice is sought in UK or Ireland

  • Provide input to local cross functional teams on status of planned and approved regulatory submissions

  • Ensure, in conjunction with Head of Regulatory Affairs, that regulatory requirements of UK & Ireland are fully represented in discussions at Global, Regional and Local levels

  • Build good relationships with internal and external stakeholders, particularly within Global Regulatory Affairs and at the Regulatory Authorities

Other 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 discrepancies

  • Support 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 meetings

  • Provide launch readiness and other commercial project team support

  • Monitor the status of competitor Marketing Authorisation’s as agreed with the local business

  • Arrange 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 systems

  • Attend and participate in local and global meetings/calls as required, and present on regulatory topics when requested

  • Review 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 SOPs

  • Actively seek to minimise risks to the business, managing risks identified and alerting the Head of Regulatory Affairs

  • Any other associated duties

Education, Experience, Skills/Competencies and Disposition

Qualifications:

Required:

  • Educated to at least degree level in a scientific discipline

  • Knowledge of national, EU converted GB, MRP, DCP & Centralised procedures in the UK and Ireland

  • Good knowledge of the development process for medicines

Desired:

  • Management qualifications

Experience:

Required:

  •  At least 8 years’ experience within a regulatory affairs role within the pharmaceutical industry

  • Proven record of success in managing a small to medium sized team and supervising staff with various levels of knowledge and expertise

  • Capable of critically reviewing and integrating scientific information from a variety of disciplines

  • Experience 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 extensions

  • Experience 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/Competencies

Required:

  • Ability to work under pressure

  • Self-motivated and ability to use initiative to resolve problems

  • Solution drive style

  • Excellent organizational, planning and time management skills

  • Computer literate, including Adobe Acrobat and Microsoft Excel

  • Effective communicator both written and verbal

  • Strong Interpersonal skills

  • Excellent attention to detail

  • Ability to work independently

  • Analytical skills

  • Negotiation skills

  • Can effectively prioritise and manage multiple competing tasks and demands

Desired:

  • Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking

  • Interest in networking internally and externally, to raise the profile of the regulatory function/Takeda.

Disposition:

Required:

  • Positive work ethic

  • Confidence

  • Enthusiasm and initiative

  • Ability to operate as a flexible team player and independently as required

  • Well organised and able to work under pressure.

  • Sense of urgency; can do attitude

  • Supports business priorities

Desired:

  • Motivated to improve existing systems

Complexity and Problem Solving

Works with very limited direction from the Head of Regulatory Affairs. Work is reviewed periodically for adequacy in meeting objectives.  Exercises good judgement in a variety of often complex situations, selecting suitable methods and techniques to maintain compliance.

Internal and External Contacts

The position reports to Head Regulatory Affairs and has line management responsibility for several Senior Regulatory Affairs Executives and Regulatory Affairs Executives.

Internal and external job contacts related to the position include: 

  • Regulatory team counterparts

  • Senior Management

  • Cross functional team members (including Quality, Commercial Teams, Market Access, Pharmacovigilance, Supply Chain, Medical Information, Medical)

  • Regulatory agency personnel

  • Company consultants/vendors

Other Job Requirements

10% Travel

Locations

London, Great Britain

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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