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:
Global Regulatory Affairs Senior Manager
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. You will contribute to defining and/or be responsible for implementing regulatory strategies spanning from first-in-human studies up to registration, including support to out-licensing activities. You will 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.
- Support the RA core-team representative in the definition and implementation of the regulatory strategy for assigned projects. You might also act as the RA core-project team representative for selected projects of less complexity.
- Lead independently or support the RA core-team representative in coordinating the timely 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. Independently or in collaboration with the RA core-team representative, 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 Clinical Teams and Study Teams, etc.
- 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 the global competitive and regulatory landscapes.
- In collaboration with the Quality Organization, contribute to the continuous assessment of internal processes, maximizing opportunities for improvement while ensuring compliance to applicable regulations.
Profile required :
- Bachelor’s degree in Health/life-sciences; a higher degree is an asset.
- 5-8 years pharmaceutical industry experience, including minimum 4 years in regulatory affairs. Global experience desired.
- Demonstrated regulatory knowledge and experience in early phases of development. Experience in Phase III-IV development, as well as in antibacterial or oncology drug development 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 activities simultaneously.
- Must be able to innovate, analyze and solve critical problems with limited supervision.
- Excellent written and communication skills in English. Knowledge of French is beneficial but not a requirement
Debiopharm can offer:
- An opportunity to work with projects at global scale, involving several Regulatory Agencies, 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.