Global Regulatory Expert
The Regulatory Affairs Expert supports the Regulatory Lead in planning and executing the necessary regulatory activities to progress our Project portfolio with the ultimate aim of obtaining marketing authorisations globally.
- Contact person for assigned responsibilities on the product, in alignment with Regulatory Lead
- Assume responsibilities for contact with 3rd party partners (mainly CROs), building strong relationships for assigned project(s), in line with the Regulatory Lead
- Responsible for providing regulatory expertise and strategy, in alignment with the Projects
- Support and deliver quality regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
- Ensure that all documents and information are adequately captured in a timely fashion in the applicable systems (document management, databases, etc).
- Prepare and communicate regulatory strategic and operational plans for assigned projects
- Maintain awareness of external regulatory environment, new guidelines and legislation
Skills and Requirements
- Experience of EU regional regulatory procedures and legislation related to drug development and clinical trial applications. From 5 to 10 years of global experience preferred in this field.
- Strategic and results focused - ability to overcome obstacles and achieve key outcomes
- Strong Project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions.
- Analytical - logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
- Build effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas
- Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
- Sensitivity to the diverse cultures comprising- the international and global environment
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.