Organisation

Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

We are currently 1200+ people, headquartered in the UK, with sites in Burton-on-Trent, Weybridge and the North East and global offices in the US, Australia, New Zealand, Japan, Hong Kong, South Africa, Singapore and Athens. Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

Role

The Regulatory Affairs Director will be responsible for the management of regulatory activities relating to applications for and maintenance of Global Marketing Authorisations for allocated licensed products.

Responsibilities 

  • Regulatory responsibility for allocated global licensed products within Clinigen Healthcare Ltd including applications for marketing authorizations in new territories, maintenance of existing licenses, variations to existing licenses, transfer of licenses to Clinigen
  • Responsible for the provision of regulatory support for allocated Managed Access programs
  • Responsible for supporting regulatory Due Diligence of potential new products and acquisitions
  • Responsible for supporting the development of regulatory strategies and provision of regulatory advice internally
  • Manage direct line reports and/or external consultants. Provide the necessary training and support to ensure that they are able to fulfil their roles
  • Create and maintain allocated SOPs for Regulatory Affairs

Requirements

  • Bachelor's Degree (or preferably higher degree) in Life Sciences or scientific discipline
  • Experience within pharmaceutical industry/CRO
  • Background in a client facing role
  • Wide experience and knowledge of Regulatory Affairs with an excellent grounding in European procedures and ideally exposure to medicines access i.e. expanded access/compassionate use/ drug development or RoW experience
  • Understanding of clinical research and clinical trials
  • Demonstrate ability to deliver results to the appropriate quality, budget and timeline metrics
  • Proven ability to successfully manage global regulatory projects
  • Proven ability to provide coaching, advice and mentoring in areas of Regulatory Affairs
  • Excellent organizational and project management skills
  • Outstanding written, verbal and interpersonal communications skills
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Ability to be effective in the business development setting, with strong presentation skills
  • Effective communicator and influencer across all mediums

Application

If this role is of interest to you, please email a recent copy of your CV and a covering letter to recruitment@clinigengroup.com and a member of the Talent Acquisition team will be in touch.