EU Regulatory Strategy Product Lead
ProClinical is advertising a vacancy for an EU Regulatory Strategy Product Lead position with a global biotechnology company. The organisation specialises in creating breakthrough therapies for rare diseases and is producing an innovative pipeline across their key therapy areas. Based in London, this position offers an exciting opportunity to join an internationally acclaimed organisation that is committed to developing high-quality solutions to meet real world problems.
- Providing support for defining the regulatory strategy and providing regional regulatory expertise for our 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 in providing guidance for the divesture and related sponsor changes.
- Experience with Clinical Trials in the EU.
- Experience with CRO and Competent Authorities & Ethics Committees.
- Experience working in Cross Functional teams globally.
- 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 +44 203 078 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.