Senior Regulatory Strategist応募後で応募 求人ID R0029898 掲載日 06/15/2021 Location:London, United Kingdom
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Senior Regulatory Strategist in our UK Head Offices in Central London, Paddington.
As our successful Senior Regulatory Strategist, you will provide technical and administrative support to the UK and Ireland Regulatory Affairs Department to:
Advise on best strategy for optimal regulatory approvals in UK for Takeda’s development product portfolio to support Takeda’s commercial activities.
Maintain existing, and obtain new, regulatory approvals in UK and Ireland in support of Takeda’s commercial activities and strategy.
You will ensure that the necessary Regulatory support is provided to Takeda UK Ltd, Takeda Products Ireland Ltd and Global Regulatory Affairs (GRA).
- Gaining optimal regulatory approvals in UK for Takeda’s development product portfolio
- Keeping 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.
- Maintaining existing and new Marketing Authorisation’s in the UK and Ireland registered via national, MRP, DCP and Centralised procedures in support of Takeda UK and Ireland’s commercial activities and strategy.
- Proving support to Global Regulatory Affairs in relation to regulatory applications when required.
- Ensuring appropriate communication with key stakeholders internally and externally, including with the Regulatory Authorities, negotiating where required to ensure a positive outcome for Takeda and providing monthly updates to the wider team.
- Maintaining familiarity with the Takeda UK and Ireland product ranges and keeping up to date with regulatory legislation and guidelines in the UK, Ireland, and the EU.
- Ensuring quality standards are consistently met and submissions are made according to the agreed deadline.
- Prepare, compile, and submit a range of regulatory applications for national, MRP and DCP products
- Cooperate with Global Regulatory Affairs to assist in the compilation of new Marketing Authorisation Applications and post-marketing applications for EU Centralised products and GB National products.
- Ensuring implementation of changes for products registered via the EU Centralised procedure locally in the UK and Ireland
- Prepare updated product information texts, ensuring they are clear and accurate, for submission with various regulatory applications
- Perform a review of current product information texts against updated Company Core Data Sheets to assess whether any changes are required
- Work with the Artwork Coordinators to create/update and implement approved artwork mock-ups via the Electronic Artwork Management System
- Ensure internal approval of updated product information by appropriately qualified medical personnel
- Ensure notification of regulatory application approvals to the QPPV office and xEVMPD mailbox where appropriate
- 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, electronic regulatory tracking database, electronic document management system, 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
- Review and process all parallel import notifications received and liaise with the global patents department as required to respond to them
- Review reports received by Global Regulatory Affairs in relation to data required for the Pharmacovigilance System Master File promptly and thoroughly and work with them to resolve any errors or discrepancies
- Provide regular updates to the Regulatory Affairs and Quality Manager regarding the activities completed/projects planned and contribute to the monthly Medical Meetings
- Build good relationships with internal and external stakeholders, particularly within Global Regulatory Affairs and at the Regulatory Authorities
- Undertake general duties or projects as required by the business and the Regulatory Affairs and Quality Manager
- 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, utilizing 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 minimize risks to the business, managing risks identified and alerting the Regulatory Affairs and Quality Manager
Key Skills, Experience and Education:
- Degree level or equivalent in a scientific discipline.
- Knowledge of national, MRP and DCP procedures in the UK and/or Ireland.
- Experience of developing strategy for new marketing authorisation applications and working within a team that successfully registered and launched a new ethical product in the EU.
- Experience within a regulatory affairs role from within the pharmaceutical industry.
- 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 writing and updating comprehensible, clear, product information documents, including development of labelling and leaflet artworks. And producing written and oral regulatory communications with clarity, accuracy and rigor.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.
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