Global Regulatory Affairs Senior Manager

Debiopharm Group

Global Regulatory Affairs Senior Manager

Debiopharm Group

Lausanne, Switzerland

Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of five companies 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 either registered or licensed out to pharmaceutical companies for worldwide marketing and sales. For our Regulatory Affairs Department based in Lausanne, we are looking for a GLOBAL REGULATORY AFFAIRS SENIOR MANAGER.

Reporting to the Global Head of Regulatory Affairs, you will be actively involved in supporting the development of innovative new medicines, including small molecules, biologics and radiopharmaceuticals. You will contribute to and/or be responsible for the implementation of regulatory strategies spanning from First-in-human studies up to registration, including support to out-licensing activities. As part of these activities you be involved in defining development paths that maximize the value of our compounds and enable early access to patients with high unmet medical need. You will also be responsible for the compliance with applicable regulations.

Main responsibilities:

  • Support the Regulatory Affairs core-team representative in the implementation of Regulatory Affairs strategy for assigned projects. When required, be the representative of Regulatory Affairs in project core-teams;
  • Represent Regulatory Affairs in various cross-functional sub-teams, such as Clinical Study Teams;
  • Lead and coordinate the 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.;
  • Work closely with functional experts to coordinate their contributions to regulatory documents;
  • Manage the regulatory CROs for coordination and preparation of submissions;
  • Review and approve documents of regulatory relevance such as Clinical Study Protocols, Clinical Study Reports, DSURs, etc.;
  • Maintain knowledge of the global competitive and regulatory landscapes.

Profile required:

  • Bachelor’s degree in Health/life-sciences; a high degree is preferred;
  • 5-8 years of experience in regulatory affairs within the pharmaceutical industry. Global (FDA and EMA) experience desired;
  • Demonstrated regulatory knowledge and experience in early phases (Phases I-III) of drug development. Experience in oncology is a plus;
  • 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 and attention to detail;
  • Excellent written and communication skills in English.

Debiopharm can offer:

  • An opportunity to work with projects at global scale 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.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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