Science & Technology

Senior Regulatory Affairs Executive

Not Specified

Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Senior Regulatory Affairs Executive.

The Senior Regulatory Affairs Executive provides full regulatory support for the product portfolio within the local operating company (LOC) and provides mentorship and training to other members of the Regulatory Affairs department.

Responsibilities

  • Management of fee requests and oversight of regulatory agency invoices and statements
  • 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).
  • Filing of regulatory submissions and approvals, both electronic and hard copy.
  • 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.

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.
  • Legacy products- Liaise with the Medical Information department to arrange upload of approved product information to the eMC and medicines.ie.
  • Legacy products – Responsible for updating all external product information databases e.g. UK EMC (Electronic Medicines Compendium) and Medicines.ie in Ireland. Liaise with marketing and commercial to ensure that all local product information used are up to date.

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 submissions.
  • 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.

Other duties as required:

  • Support EU strategy on specific projects on development/marketed products
  • 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 (SOPs) to ensure they comply with UK and
  • Irish regulatory legislation and with Global Quality principles, standards, policies and SOPs

Education, Experience, Skills

  • Minimum of 5 years of experience in pharmaceutical regulatory affairs
  • 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 artworks.
  • Experience of producing written regulatory communications with clarity, accuracy and rigor.
  • Knowledge of the Centralised procedure.
  • Experience of working in a local affiliate regulatory affairs department.
  • Experience of working within electronic regulatory tracking databases and document management systems.
  • Excellent organizational, planning and time management skills.
  • Computer literate, including Adobe Acrobat and Microsoft Excel.
  • Effective communicator both written and verbal, strong interpersonal skills
  • Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking.

Employment Type Contract

Advertiser Type Agency