Regulatory Affairs - Manager

Location Hemel Hempstead
Discipline: Regulatory Affairs
Job type: Permanent
Salary: ££50,000 - £75,000 + Bonus
Contact name: Owain Walsh

Contact email: owain.walsh@rbwconsulting.com
Job ref: 23736
Published: 17 days ago
Expiry date: 05 June 2022

RBW Consulting has an opportunity for a Regulatory Affairs professional to join a pioneering pharmaceutical as they go through further expansion.

The role is to be based from our client’s newly established, and contemporary offices in Hemel Hempstead with added flexibility to working remotely (1-2 days a week).

You’ll be joining a friendly and supportive team of Regulatory individuals focused on bringing our client’s leading product to new markets and ensuring it remains the drug of choice.

This is a great opportunity to join as the organisation continues to grow and places a real emphasis on personal and career development.

The role:

  • Assist the planning, preparation, and submission of MA applications in North America, Australia/New Zealand and addressing RFI/RTQ Response, post-approval variations (Admin, Quality, Clinical & safety changes), renewals, post-marketing commitment submissions, and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia, and the UK.
  • Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines, and conditions in these markets.
  • Working alongside regulatory colleagues to transfer MAs worldwide.
  • Reviewing and submitting artwork and labelling changes, including management of third-party artwork house.
  • Managing external pharmacovigilance, medical information 3rd party agent, local translators, trademark providers, publishing, and consular service providers.
  • Building and maintaining effective relationships with external clients/partners/local distributors alongside partner’s regulatory teams.
  • Managing/supporting a range of changing project demands.
  • Gap analysis of regulatory documentation, identification of potential challenges, and proposal of solutions.

Essential Requirements:

  • Bachelor’s degree equivalent or higher qualification within life science
  • Knowledge of MHRA regulations, GXP requirements, ICH guidelines, and EU DCP/National lifecycle maintenance.
  • Authoring & preparation of regulatory packages and documents for submissions
  • Experience in working MA transfers
  • Reviewing/annotating and approving artworks and labeling
  • Experience working with regulatory agencies to clarify and resolve regulatory matters

The Benefits:

As well as joining a connected and supportive team with further development, our client offers:

  • 31 Days’ holiday including statutory, plus birthday
  • Health insurance
  • The opportunity to attend international conferences and training for continued development
  • The opportunity to make an individual contribution to the organsations

Interested… Then apply today with a CV or contact Owain at RBW consulting for more information and a confidential chat. 0191 6257 861