2 days ago

Associate Director, Global Regulatory Affairs

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Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investment management. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for worldwide marketing and sales.

For our Regulatory Affairs Department based in Lausanne, we are looking for a:

Associate Director, Global Regulatory Affairs

Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investment management. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for worldwide marketing and sales.

For our Regulatory Affairs Department based in Lausanne, we are looking for a:

Reporting to the Global Head of Regulatory Affairs (RA), you will be actively involved in supporting the development of innovative new medicines, including small molecules, biologics and/or radiopharmaceuticals. As the RA project core-team representative, you will be responsible for defining and implementing regulatory strategies from first-in-human studies up to registration. You will also be responsible for ensuring compliance with applicable regulations and will contribute to out-licensing activities. Your role is key for defining development paths that maximize the value of our compounds and enable early access to patients with high unmet medical need.

 

Main 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.

 

Profile required :

  • Bachelor's degree in scientific discipline; post-graduate scientific degree is preferred.
  • 8-10 years pharmaceutical industry experience, including 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.

 

Debiopharm can offer

  • 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.

CP 5911 /Chemin Messidor 5-7 1002 Lausanne