Head of Regulatory Affairs/International Site Activation
The Head of Regulatory Affairs (International Site Activation) is responsible for developing a robust global site activation and regulatory strategy for assigned projects. (S)he is responsible for managing and developing the department staff and their performance. (S)he serves as an expert reference for other members of the regulatory (International Site Activation) department to ensure appropriate execution of the developed site activation strategy.
Main responsibilities & Major Activities:
- Working in a team matrix environment (involving Project Management, Medical Affairs, Clinical Operations, and others) oversees & implements an efficient and accelerated site activation strategy
- Ensures appropriate resourcing of staff & workload repartition
- Improves staff efficiency and effectiveness at prioritizing work
- Ensures initial and continuous training as well as professional development & regulatory advice to all members of the department
- Ensures quality control of project deliverables
- Provides ongoing updates on changes in the regulatory environment related to clinical trials activation; including the implementation of the EU Clinical Trials Regulation N° 536/2014.
- Develops and maintains SOPs in compliance with applicable regulations
- Advises on and reviews regulatory documents to ensure compliance with applicable regulations
- Collaborates closely with the Project Management and Clinical Operations teams to proactively identify & communicate risks, existing roadblocks along the critical path, and direct corrective actions to mitigate.
- Participates to Portfolio Steering Committees meetings, and meetings with third-parties
- Master degree in relevant field
- 8 years of relevant experience in international clinical trial regulatory/site activation environment from a sponsor perspective in a managerial position
- Good knowledge of current and future EU regulatory environment and related impacts on the work organization.
- Ability to coordinate work transversally with other units, reach deliverables by deadlines, result oriented
- Expertise in quality control of regulatory submission documents
- Excellent proven team management experience
- Good organization skills, ability of multi-task
- Excellent written and verbal English skills.