An excellent opportunity has arisen to join a leading pharmaceutical company as a Associate Director, Global Regulatory Affairs.
Reporting to the Global Head of Regulatory Affairs, you will be a core-team member within a matrix organization and will be actively involved in the development of therapeutic medicines from POC through approval or out licensing (whichever comes first) thereby contributing to strategy of the drug development path as well as to compliance with applicable regulations.
*Develop and implement global (FDA, EMA, etc.) RA strategy for the assigned projects.
*Serve as the primary interface for FDA/EMA on assigned projects and prepare the team for FDA/EMA and other health agency meetings.
*Lead the preparation of submissions, which may include INDs/CTAs, Briefing Documents, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc. Work with functional groups to define their contributions to submissions and lead regulatory activities for projects assigned.
*Manage the regulatory CROs for coordination and preparation of submissions.
*Represent Regulatory Affairs in the core-team. Contribute to the core-team by providing the regulatory strategy. Also, represent RA in other various cross-functional teams, including Project Teams, Clinical Teams and Study Teams, etc. Present and defend regulatory plans to the senior management and project review boards.
*Maintain knowledge of global competitive landscape, regulatory environment, and regulations.
*Review and approval of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, and other documents.
*Bachelor's degree in scientific discipline; post-graduate scientific degree is preferred.
*Demonstrated experience in multiple phases of drug development. Experience in antibacterial or oncology drug development is preferred.
*8 years pharmaceutical industry experience, including minimum 4 years in regulatory affairs. Global (FDA and EMA) experience desired.
*Thorough knowledge of the drug development process.
*Demonstrated experience in handling challenging regulatory obstacles.
*Thorough knowledge of Fast Track/ Breakthrough Designation/ Prime. Demonstrated active hands-on experience in these submission 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 projects simultaneously.
*Must be able to innovate, analyze and solve critical problems with minimal supervision and attention to detail.
*Excellent written and communication skills in English. Communication knowledge in French would be beneficial.
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