Senior Regulatory Affairs ExecutiveApply Now Email Me Job ID SR0046039 Date posted 01/29/2020 Location: London, United Kingdom; Paddington, United Kingdom
Senior Regulatory Affairs Executive
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As a Senior Regulatory Affairs Executive , you will be empowered to prepare compilation and submission of UK/IE regulatory applications, and the management of regulatory application approvals, In this role, you will contribute to Takeda’s mission.
A typical day will include:
Preparation, compilation and submission of UK/IE regulatory applications for national, MRP and DCP products, including:
- management of fee requests and oversight of regulatory agency invoices and statements, including annual fees.
- preparation of submission documentation, including preparation of local product information and management of requests for mock-ups (ensure regulatory review of artworks, applying NPSA principles for injectable medicines).
- liaison with publishing.
- filing of regulatory submissions and approvals, both electronic and hard copy.
- completion of post-submission actions (i.e. update of relevant quality and document management systems, notifications to commercial teams).
- 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.
- 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.
Management of regulatory application approvals, including:
- implementation of product information changes (including for Centralised products).
- implementation of approved mock-ups.
- internal approval of updated product information by appropriately qualified personnel.
- notification of regulatory application approvals to the QPPV office, xEVMPD mailbox, quality and document management systems.
- liaise with the Medical Information department to arrange upload of approved product information to the eMC and medicines.ie.
Regulatory contact point for local, international and global teams on UK/Irish regulatory matters:
- manage direct interactions with local UK/IE regulatory authorities for national licenses, for the national phase of MRP/DCP procedures and in relation to local activities required for Centralised products (i.e. risk minimization materials).
- facilitate interactions by the European or Global regulatory personnel in the case of Centralised procedures where the UK/Ireland is the rapporteur/co-rapporteur or where Scientific Advice is sought.
- provide input to local cross functional teams on status of planned and approved regulatory submissions.
- provide regulatory advice to support the UK & Ireland Business strategy.
- ensure 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.
Mentor and trainer for other team members, ensuring:
- oversight and review of draft submissions and execution of post-approval actions prepared by junior team members to ensure quality standards and compliance targets are met.
- training on key regulatory systems/processes
- sharing of best practice and intelligence gathered
Other duties as required:
- support EU strategy on specific projects on development/marketed products
- oversee preparation of responses to periodic requests (e.g. tender support, HTA submissions, shortage notifications, unlicensed medicines requests, PSMF reviews)
- provide launch readiness and other commercial project team support
- monitor the status of competitor marketing authorisation’s as agreed with the local business
- review and process all parallel import notifications received and liaise with the global patents department as required to respond to them
- 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
- ensure quality standards are consistently met and submissions are made according to the agreed deadline.
- keep up to date with regulatory legislation and guidelines in the UK, Ireland and the EU.
- actively seek to minimize risks to the business, managing risks identified and alerting the Regulatory Affairs and Quality Manager
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 realize 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.
Empowering Our People to Shine
Discover more at takedajobs.com
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