- Responsible for defining the Global RA strategy (FDA, EMA, China, Japan, etc.) for assigned projects and lead its implementation.
- Serve as the primary interface for FDA/EMA on assigned projects and prepare the team for meetings with FDA/EMA and other Regulatory Agencies.
- Lead and coordinate 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. 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 the project core-team, Clinical Teams and Study Teams, etc. Present and defend regulatory plans to the senior management and project review boards.
- 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 global competitive landscape, regulatory environment, and regulations.
- In collaboration with the Quality Organization, contribute to the continuous improvement of internal processes, maximizing opportunities for improvement while ensuring compliance to applicable regulations.
- Bachelor’s degree in a scientific discipline; post-graduate scientific degree is preferred.
- 8-10 years pharmaceutical industry experience, including a minimum 6 years in regulatory affairs. Global experience desired.
- Thorough knowledge of the drug development process with demonstrated experience in multiple development phases. Experience in antibacterial or oncology drug development is strongly preferred.
- Demonstrated experience in successfully managing challenging regulatory obstacles and/or complex development programs.
- 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, analyze and solve critical problems with minimal supervision.
- Excellent written and communication skills in English. Knowledge of French is beneficial but not a requirement
- An opportunity to act as Global Regulatory project leader working with several Regulatory Agencies world-wide, in a company at the forefront of the most advanced scientific developments in the industry
- A diverse and dynamic environment where innovation, trust in people, and entrepreneurship are valued.
|Job Category||REGULATORY AFFAIRS|