Regulatory EU Lead
A leading pharmaceutical company is seeking to recruit a Regulatory EU Lead to their office in London. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
- Part of the EU RA strategy team, providing support for defining the regulatory strategy.
- Providing regional regulatory expertise for the company's program.
- Executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of this program in the EU as dictated by business objectives.
- Interacting with the EMA and national Regulatory Agencies in the EU Member States as needed to ensure timely submission and approval of submission related to the development of the program.
Skills and Requirements:
- Experience in handling CTAs with Competent Authorities and Ethics Committees as well as submissions to EMA and provide guidance for the divesture & related sponsor changes.
- Key experience in Clinical Trials in the EU, Experience in communication with CRO & Competent Authorities & Ethics Committees, working in Cross Functional teams globally.
- Motivated and ambitious to work in a ring-fenced program.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at 0203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.