P2624 - Global Regulatory Affairs Specialist/Manager
On-siteLausanne, Vaud, Switzerland
Job Summary
Develop and implement global regulatory strategies for assigned drug development projects, managing external vendors and tracking submissions across multiple jurisdictions including INDs, orphan drug applications, and fast track designations. Represent regulatory affairs in cross-functional clinical trial teams, review regulatory documents such as protocols and clinical study reports, and coordinate contributions from functional experts. Maintain knowledge of the global regulatory landscape to assess impacts on projects and contribute to establishing standard operational procedures that ensure compliance. This role supports the development of innovative medicines in oncology and anti-infective areas within a matrix environment, requiring a BSc in Life-Sciences and at least three years of regulatory affairs experience.
Required Qualifications
- BSc Degree in Life-Sciences
- At least 3 years of regulatory affairs experience in the field of drug development, including experience in managing clinical trials
- Demonstrated understanding of regulatory procedures in the EU and/or US
- Independent, results driven, team-oriented
- agile individual with the ability to influence outcomes
- Excellent organizational, communication and time management skills
- good analytical skills with a solution driven mindset
- Proficiency in English (oral and written)
Desired Qualifications
- a higher degree
- Knowledge of French
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