- Support the RA core-team representative in the definition and implementation of the regulatory strategy for assigned projects. You might also act as the RA core-project team representative for selected projects of less complexity.
- Lead independently or support the RA core-team representative in coordinating the timely preparation of several submissions, such as: INDs/CTAs, Briefing Documents to support meetings with Health Authorities in several jurisdictions, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc. Independently or in collaboration with the RA core-team representative, you will guide cross-functional teams in defining the best strategy for each submission, their content and the contribution of each team member to their preparation.
- Manage regulatory CROs in charge of publishing and performing local submissions.
- Represent Regulatory Affairs in several internal cross-functional teams, like Clinical Teams and Study Teams, etc.
- Review and contribute to the approval of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, and other documents of regulatory relevance.
- Maintain knowledge of the global competitive and regulatory landscapes.
- In collaboration with the Quality Organization, contribute to the continuous assessment of internal processes, maximizing opportunities for improvement while ensuring compliance to applicable regulations.
- Bachelor’s degree in Health/life-sciences; a higher degree is an asset.
- 5-8 years pharmaceutical industry experience, including a minimum of 4 years in regulatory affairs. Global experience desired.
- Demonstrated regulatory knowledge and experience in the early phases of development. Experience in Phase III-IV development, as well as in antibacterial or oncology drug development is preferred.
- Necessary skills: Independent, result-driven, team-oriented, agile individual with the ability to influence outcomes.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing activities simultaneously.
- Must be able to innovate, analyse and solve critical problems with limited supervision.
- Excellent written and communication skills in English. Knowledge of French is beneficial but not a requirement
|Job Category||REGULATORY AFFAIRS|