Global Regulatory Affairs Specialist/Manager

Global Regulatory Affairs Specialist/Manager

Debiopharm Group

Lausanne, Switzerland

Your Mission:

Reporting to the Program Lead Global Regulatory Affairs, your primary goal is to bring technical and operational expertise toward global regulatory strategies from First-In-Human studies through to registration. Working in a matrix environment, you will collaborate closely across cross-functional teams to maximize compound value, ensure regulatory compliance, and navigate global competitive landscapes.

Key Responsibilities:

• Strategy & Submissions: Support senior team members in developing and executing global regulatory strategies. Assist in managing external vendors (e.g., CROs) and preparing/tracking multi-jurisdictional filings (INDs/CTAs, Briefing Documents, Orphan Drug Applications, PIP/PSP, Fast Track, Breakthrough Designation, PRIME, etc.).
• Cross-Functional Collaboration: Act as the Regulatory Affairs representative on cross-functional sub-teams, including Clinical Study Teams. Partner with functional experts to coordinate seamless input into regulatory documentation.
• Document Review: Actively participate in the review of key regulatory-relevant documents, such as Clinical Study Protocols, Clinical Study Reports, DSURs, and related filings.
• Landscape Assessment: Maintain up-to-date knowledge of the global competitive and regulatory landscape, evaluating the potential impact of changes on assigned projects.
• Process Excellence: Contribute to establishing and revising Standard Operating Procedures (SOPs) to enhance process efficiency and ensure ongoing regulatory compliance.

Requirements

Your Profile:

• Education: Bachelor’s degree in Life Sciences; an advanced degree (Master's/PhD) is preferred.
• Experience: Minimum of 4 years of regulatory affairs experience within R&D drug development, including hands-on experience managing clinical trials.
• Regulatory Expertise: Solid understanding of EU and/or US regulatory procedures.

Skills & Core Competencies:

• Drive and Mindset Independent, results-driven, agile, and team-oriented with a proven ability to influence outcomes.
• Organization and Working Style : Excellent communication, time management, and analytical skills, equipped with a solution-driven approach to manage multiple tasks simultaneously.
• Languages: Proficiency in oral and written English is required; knowledge of French is an asset.