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Regulatory Affairs Manager
London, United Kingdom
Business Area Overview
The Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people.
Across the EUCAN BU, patients come first in every decision we make. We develop strategic partnerships which deliver value for society and create a culture within which our people can thrive and reach their full potential.
Our mission is to empower and enable our people to fulfill their potential by embracing diversity and creating a high-performance, collaborative working environment. In the EUCAN region integrity is one of our key values. We put patients, trust and reputation before business and this is one of the main reasons why our people choose to work here.
What makes a successful team member within EUCAN at Takeda?
I know that I need to work in a place where I can grow and be challenged, and what motivates me the most is to make a difference. I think what we offer here at Takeda truly helps patients. And it’s important to bring others along on that journey.Rebecca Yu VP of Patient Value & Access
Believe in your own ability to do the things you want to do. If you do that, things will happen.Heena Howitt Country Medical Lead Genetic Diseases
The faster we help someone get a true diagnosis of their underlying condition, the faster we can offer a treatment that can help them get back to living their life and improve their future outlookChristian Downton Business Unit Director Rare Metabolic Diseases
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 11 companies to receive Top Global Employer® status for 2022.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Regulatory Affairs ManagerJob ID R0053868 Date posted Nov. 25, 2021 Location London, United Kingdom
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.
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.
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
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
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
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.
Experience of working within a team that successfully registered and launched a new ethical product in the EU.
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
Can effectively prioritise and manage multiple competing tasks and demands
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.
Positive work ethic
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
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
Cross functional team members (including Quality, Commercial Teams, Market Access, Pharmacovigilance, Supply Chain, Medical Information, Medical)
Regulatory agency personnel
Other Job Requirements
LocationsLondon, Great Britain
Time TypeFull time
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