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, Asia Pacific, South Africa, and across Europe. 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.
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Associate - Intelligence is accountable for ensuring that advice and support relating to the regulation of medicines is provided to internal customers and external Clinigen clients, with a particular focus on ethical unlicensed supply of medicinal products.
This is a permanent position and will be based at our Burton on Trent site.
Responsibilities (Not exhaustive)
- Keep up to date with and implement/cascade new information pertaining to the regulation of medicines in the US, EU and RoW, according to relevance for Clinigen’s activities in unlicensed and commercial medicines
- Support the collation and maintenance of in-house trackers and/or databases to ensure that up to date regulatory information is available to key functions concerning unlicensed medicine supply
- Provision of country specific regulatory guidance and training in Customer Services and ad hoc support to other team members in response to customers queries concerning unlicensed medicine supply
- Conduct impact assessments for the business on any key updates in the Regulatory Affairs arena, with support of senior members of the Regulatory Affairs team
- Provide advice and support on regulatory intelligence to regulatory team members and other Clinigen cross functional teams on special topics
- With the support of senior members of the Regulatory Affairs team, advise on plans for potential or newly granted programmes for unlicensed medicines, review client documentation, and advise on exit strategies
- Develop and maintain relationships with assigned clients with programmes for unlicensed medicines, with the support of senior members of the Regulatory Affairs team, as required.
- Develop and maintain relationships with external regulatory agencies
- Bachelor's Degree or higher in Life Sciences (or equivalent) highly preferred
- Experience within pharmaceutical industry/CRO, preferably in Regulatory Affairs, Quality or Pharmacovigilance
- Essential to have experience working with summarising and presenting scientific/regulatory data
- Extensive knowledge of MS Office Applications and systems
- Excellent organizational and project management skills, including ability to prioritise work effectively
If this role is of interest to you, please email a recent copy of your CV and a covering letter to firstname.lastname@example.org and a member of the Talent Acquisition team will be in touch.