P2626 - Responsable Réglementaire Programme Global

Jobup; Lausanne; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Debiopharm in Lausanne, Switzerland, seeks a Global Program Regulatory Lead to shape global regulatory strategies for innovative medicines from preclinical through registration. Based in our Regulatory Affairs team, you will drive agency interactions, submissions, and cross-functional governance to maximize compound value.

You will mentor junior team members, collaborate with BD and lifecycle teams, and navigate complex regulatory landscapes to accelerate access for patients with high unmet

Qualifikationen

• Bachelor’s degree in life sciences; Master’s or PhD/PharmD strongly preferred.
• 10+ years of regulatory affairs experience in innovative medicines, oncology or anti-infectives.
• Direct experience leading meetings with regulatory agencies (US & EU required).
• Proven record of leading cross-functional teams on major regulatory deliverables.
• Ability to lead matrix teams and influence across a complex organization.
• Independent, results-driven professional with strong problem-solving skills.
• BD and lifecycle awareness including in/out-licensing and lifecycle strategies.

Aufgaben

• Define, develop, and execute global regulatory strategies across projects.
• Lead agency meetings and negotiations with FDA, EMA, and other authorities.
• Oversee global submissions including INDs/CTAs, briefing documents, and designations.
• Represent Regulatory Affairs on project teams and governance bodies.
• Coordinate contributions for CSRs, SAPs, and DSURs.
• Assist in-licensing/out-licensing assessments and monitor regulatory landscape.
• Lead regulatory sub-teams and manage CROs to ensure quality.
• Drive process optimization within Regulatory Affairs and cross-functionally.
• Mentor junior regulatory professionals and contribute to team development.

Kenntnisse

Regulatory leadership

Stakeholder management

Strategy development

Regulatory submissions

Cross-functional leadership

Communication in English

French language advantage

Ausbildung

Bachelor’s degree in life sciences

Master’s degree or PhD/PharmD preferred

Jobbeschreibung

Together, we innovate, we impact, we grow !

At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families.

Through our unique “development only” model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster.

Are you ready to pioneer regulatory pathways that bring life-saving therapies to patients faster?

We are currently looking for a dynamic Global Program Regulatory Lead to shape the future of our pipeline. In this pivotal role, you will be the strategic regulatory voice across Project Teams, defining global regulatory strategies for innovative medicines—including small molecules, biologics, and radiopharmaceuticals from first-in-human studies through to registration. Your mission is to maximize compound value, navigate complex global regulatory landscapes, and accelerate early access for patients with high unmet medical needs. The role is part of the Regulatory Affairs team and will be based at our Headquarters in Lausanne, Switzerland.

Global Program Regulatory Lead

Permanent role, full time | Lausanne, Switzerland

Executive Summary of Responsibilities

As the Global Program Regulatory Lead, you are responsible for defining, developing, and executing end-to-end global regulatory strategies across assigned development projects. Reporting to the Head of Regulatory Affairs, you will act as the primary interface with health authorities (FDA, EMA, and beyond), lead cross-functional regulatory sub-teams, support business development opportunities, and mentor junior regulatory professionals to drive operational excellence and compliance.

Key Tasks & Responsibilities

• Strategic Regulatory Leadership: Develop and implement end-to-end global regulatory strategies for innovative drug projects across preclinical, clinical, and registration phases.
• Health Authority Interaction: Act as the primary interface for key regulatory agencies (FDA, EMA, etc.), coordinating and leading agency meetings and negotiations.
• Global Submissions: Accountable for key global filings including INDs/CTAs, Briefing Documents, Orphan Drug Designations, PIP/PSPs, and expedited pathways (Fast Track, Breakthrough, PRIME).
• Cross-Functional Governance: Represent Regulatory Affairs on Project and Clinical Study Teams, presenting and defending strategic plans to internal governance bodies.
• Document Ownership: Review, approve, and coordinate expert contributions for crucial deliverables such as Clinical Study Protocols, CSRs, SAPs, and DSURs.
• Business Development & Intelligence: Support in-licensing evaluations and out-licensing teams while monitoring the competitive and regulatory landscape to mitigate project impacts.
• Vendor & Sub-team Oversight: Lead matrixed regulatory sub-teams and manage external regulatory vendors/CROs to ensure high-quality execution.
• Processexcellence:Strive for continuous processoptimization withinRA and cross-functionally, including contributing to SOP management.
• PeopleManagement:Manage,coachand contribute to the development ofjunior regulatory team members.

Profile Required

• Educational Foundation: Bachelor’s degree in life sciences; a Master’s degree or PhD/PharmD is strongly preferred.
• Regulatory Expertise: 10+ years of regulatory affairs experience in innovative medicines, preferably in oncology or anti-infectives, with thorough knowledge of the overall drug development process; experience with regulatory strategies spanning first-in-human through Phase 3 design and registration a strong asset.
• Agency Engagement: Proven track record of directly leading meetings with regulatory agencies (US & EU experience required; other global markets an asset).
• Submission Track Record: Demonstrated success leading cross-functional teams in preparing major regulatory deliverables, expedited pathways, and global trial applications.
• Matrix Leadership: Strong ability to lead cross-functional sub-teams and influence outcomes across a matrix organization with agility and purpose.
• Problem-Solving & Autonomy: Independent, results-driven professional capable of innovating, analyzing, and solving critical regulatory challenges with minimal supervision.
• BD & Lifecycle Awareness: Familiarity with business development assessments (in/out-licensing) as well as lifecycle management or innovative formulation strategies.
• Communication & Languages: Excellent organizational and communication skills in English; fluency or working knowledge of French is a distinct advantage.

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.