Regulatory Affairs Specialist
Oliver Care is recruiting for a Regulatory Affairs Specialist to join a company in the pharmaceutical industry at their site based in Berkshire on a permanent basis.
The main purpose of the role will be to:
- Gain and maintain UK and Ireland Marketing Authorisations, Clinical Trial Applications and Manufacturing Licenses and prepare and submit High quality applications.
- Provide regulatory support and advice to local business units as well as supporting Global Regulatory Affairs colleagues in delivering strategic and operational regulatory plans and activities and providing local regulatory advice on any global or regional projects as required.
- Support the Associate Director, UK Regulatory Affairs in ensuring compliance of the companies activities with current external regulatory requirements and internal quality management system.
Further responsibilities will include:
- Acting as the primary contact with the MHRA and IMB and develop and maintain appropriate relationships with relevant contacts attending authority meetings when required.
- Participating in Business Unit meetings, developing and maintaining strong working relationships with key medical, clinical research and commercial colleagues in the UK and Ireland and maintain up to date knowledge of current regulatory requirements and future trends.
- Managing and approving labelling and leaflet artworks for UK and Ireland products
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in a scientific discipline with proven experience in a UK or European regulatory role and knowledge of the current EU/UK regulatory framework.
- A basic understanding of the UK commercial and healthcare environment for medicines and an understanding of GxP requirements.
- Excellent written and oral communication skills with ability to negotiate as well as strong attention to detail and the ability to plan organise and coordinate multiple tasks effectively.
This is an excellent opportunity to join a global speciality-driven pharmaceutical company with innovative Research and Development and benefits include an annual bonus.
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30669 in all correspondence.