# P2624 - Global Regulatory Affairs Specialist/Manager

> Debiopharm · Lausanne, Switzerland (Hybrid) · Full-time · Posted 2026-07-21

**Workplace:** hybrid

**Department:** Regulatory Affairs

## Description

Mission: 

Reporting to the Program Lead, Global Regulatory Affairs, the Global Regulatory Affairs Specialist/Manager is actively involved in supporting the development of innovative new medicines, including small molecules, biologics and radiopharmaceuticals. 

Working in a matrix environment, the Global Regulatory Affairs Manager supports and works in close collaboration with Senior Regulatory Affairs Team members in defining development paths that maximize the value of our compounds and enable early access to patients with high unmet medical need. The Global Regulatory Affairs Manager contributes with technical and operational expertise to the implementation of regulatory strategies spanning from First-in-human studies up to registration. Additionally, this role ensures compliance to applicable regulations and relevant processes when performing assigned tasks. 

Main responsibilities: 

-   Supports Senior RA team member in the: 

-   Development and implementation of the global RA strategy for assigned projects; 

-   Management of external vendors such as CROs; 

-   Preparation and tracking of submissions in several jurisdictions, such as: INDs/CTAs, Briefing Documents to support meetings with Regulatory Agencies, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc; 

-   Represents RA in cross-functional sub-teams, such as Clinical Trial Teams; 

-   Participates in the review of documents of regulatory relevance such as Clinical Study Protocols, Clinical Study Reports, DSURs, etc; 

-   Works closely with functional experts to coordinate their contributions to regulatory documents; 

-   Maintains knowledge of global competitive and regulatory landscape and contributes to the assessment of the impact changes might have on assigned projects; 

-   Contributes to establishing and revising standard operational procedures to maximize the efficiency of processes and ensure compliance to regulations.

## Requirements

Profile required: 

-   BSc Degree in Life-Sciences; a higher degree is preferred; 

-   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; 

-   Necessary skills: Independent, results driven, team-oriented; agile individual with the ability to influence outcomes; 

-   Excellent organizational, communication and time management skills needed to manage multiple ongoing tasks/projects simultaneously; 

-   Possess good analytical skills with a solution driven mindset; 

-   Proficiency in English (oral and written). Knowledge of French is an asset

## Benefits

### What we Offer: 

-   Being part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day 

-   Partner with teams across disciplines, at the forefront of oncology and anti-infective development 

-   An inclusive and respectful workplace — proud to be Equal-Pay certified 

-   Grow in a culture that values people, purpose, and performance 

-   A chance to grow, share, and shape the future of healthcare 

### What to Expect in the Recruitment Process: 

If your application is selected, you’ll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a panel interview and reference checks. Communication is handled via Workable—check your spam folder for emails from \*@outbound.workable.com. 

We do not accept unsolicited applications from agencies or recruiters.

## Apply

[Apply at Debiopharm](https://apply.workable.com/debiopharm/j/9B3B7116FA/apply)

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