Associate Director Global Regulatory Affairs

switzerland
Posted 5 months ago

Key Responsibilities

  • 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.

Requirements

  • 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 Features

Job CategoryREGULATORY AFFAIRS

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