Regulatory Affairs Executive

1 week ago

London, Greater London, United Kingdom Takeda Pharmaceutical Full time

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 a

Regulatory Affairs Executive
at our location Paddington, London.


The
Regulatory Affairs Executive provides technical and administrative regulatory support for the Takeda product portfolio within the local operating company (LOC) UK/Ireland.


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.
  • Ensuring that the necessary regulatory support is provided to local, regional, and global regulatory affairs functions and collaborate fully with other local and global functions including commercial teams.
  • 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.
  • Regulatory contact point for local, international, and global teams on UK/Irish regulatory matters
  • Support with periodic requests (e.g. tender support, HTA submissions, shortage notifications, unlicensed medicines requests, PSMF reviews) and ensure quality standards are consistently met and submissions are made according to the agreed deadline.
  • Provide launch readiness and other commercial project team support, as agreed with Regulatory Affairs Manager
  • In cooperation with the Regulatory Affairs Manager and Senior Regulatory Executives, 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
- 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 Manager

Your profile:

  • BSc in a scientific discipline or equivalent qualification
  • At least 3 years' experience in the pharmaceutical industry in either regulatory affairs or a closely related discipline
  • Completion of TOPRA Basics of Regulatory Affairs Course is advantageous
  • Proven experience and relationship with UK or Ireland Regulatory Authorities
  • Experience of writing and updating comprehensible, clear, product information documents, including development of labelling and leaflet texts
  • Keeping up to date with Pharmaceutical Regulations and intelligence and sharing accordingly
  • Experience of producing written pharmaceutical communications with clarity, accuracy, and rigor.
  • Knowledge of the Centralised procedure and experience of working within electronic regulatory tracking databases, electronic quality management systems and document management systems is beneficial
  • Ability to handle multiple tasks and work under pressure
  • Excellent organizational, planning, time management skills and excellent attention to detail
  • 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

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.


Locations:

GBR - Paddington

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

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