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Job Description
People First - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. Our people are the heart of Takeda.
Within our Regulatory Affairs department, we are looking for an experienced
Senior Regulatory Affairs Executive
at our location Paddington, London.
The Senior Regulatory Affairs Executive provides technical and administrative regulatory support for the Takeda product portfolio within the local operating company (LOC).
Your tasks in detail:
- Maintaining existing, and obtaining new, marketing authorisations in UK and Ireland for national, MRP, DCP and Centralised products in support of Takeda’s commercial activities and strategy, ensuring conformance to national and EU Drug Laws.
- Prepare, compile, and submit a range of regulatory applications for national, MRP and DCP products.
- Keeping up to date with regulatory legislation and guidelines in the UK, Ireland, and the EU.
- 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 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)
- Ensure accurate regulatory records are kept.
- Act as regulatory contact point for local, international, and global teams on UK/Irish regulatory matters.
- Provide input to local cross functional teams on status of planned and approved regulatory submissions and provide regulatory advice to support the UK & Ireland Business strategy
- Build good relationships with internal and external stakeholders, particularly within Global Regulatory Affairs and at the Regulatory Authorities
Your profile:
- At least 5 years’ experience within a Regulatory Affairs role 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.
- Keeping up to date with Regulatory intelligence and sharing accordingly.
- Contributing usefully to regulatory discussions.
- Experience of producing written regulatory communications with clarity, accuracy, and rigor.
- Ability to handle multiple tasks and work under pressure
- Excellent organizational, planning and time management skills
- Computer literate, including Adobe Acrobat and Microsoft Excel
- Effective communicator both written and verbal, strong interpersonal skills
- Good Interpersonal skills
What you can look forward to with us:
- Appreciative working atmosphere in an international and exciting working environment with a wide range of development opportunities
- Independent work with the opportunity to play a part in shaping an innovative company
- Professional and personal development opportunities
- Flexible working hours and home office (only 40% in the office)
Empowering our people to shine
At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world. Learn more at takedajobs.com.
Diversity, Equity and Inclusion
Takeda is committed to foster diversity, equity and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age or disability.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!
For further questions, please contact: Jennifer Kriedemann | Talent Acquisition Partner EUCAN | E-Mail: jennifer.kriedemann@takeda.com
