The Company
Our client is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world.
With clients, staff and offices around the globe, we offer a varied and international experience.
Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations. As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of our client is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations.
The role
We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs team. The team is based in the UK, but we are happy to accept candidates from the US, Ireland, Portugal, Spain and Germany. This role will have the unique opportunity of working both within our Clinical Development (CRO) and our Early Access Programs Business Areas, which is a possibility not provided elsewhere in the market.
Work to deliver strategic and operational regulatory support and expertise to the Regulatory team and clients to ensure efficient and compliant set-up, maintenance and close-out of projects
Reporting to: Associate Director, Regulatory Affairs
Proven Personal Drive to achieve results
At least 7 years’ experience in a regulatory affairs related role
Proven ability to interpret and apply complex regulations
In-depth knowledge of drug development process and pharmaceutical industry experience
Effective time management skills and ability to manage competing priorities
Comprehensive Line Management skills
Excellent communication skills
Knowledge of GDP, PV and GCP
High attention to detail
Medical writing experience, ideally of regulatory dossiers