Senior Regulatory Affairs Manager
Scope of the job
The Senior Regulatory Affairs Manager works under the hierarchical supervision of the Head of Regulatory Affairs Department.
As a Senior Regulatory Affairs Manager (Sr RAM) you play a role in the management of the Regulatory Affairs Department for workload planning and staff coaching throughout the whole life cycle of the clinical trial applications across Europe.
Main responsibilities / Major Activities
- First entry port of any new project that requires regulatory advice during the planning phase.
- Provide ongoing updates on changes in the regulatory environment
- Advise on and review regulatory documents to ensure compliance with applicable regulations and propose actions, if required
- Ensure together with the Head of Dept. initial and continuous training as well as personal development & regulatory advice to all members of the RAU
- Support the Head of Department in the development of procedures and templates
- Back up of the Head of Dept. at relevant meetings (General team meetings, meetings with industry etc.)
- Master degree in life Sciences
- 8 years of relevant experience in international clinical trial regulatory environment from a sponsor perspective in a management/decision making position
- Good knowledge of current and future EU regulatory environment and related impacts on the work organization.
- Can demonstrate the ability to coordinate work transversally with other units, reach deliverables by deadlines
- Can demonstrate expertise in QC of regulatory submission documents
- Excellent proven team management experience, familiar with project management tools for planning
- Good organization skills, ability of multi-task
- Excellent written and verbal English skills.