P2626 Global Program Regulatory Lead

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 were 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 this pivotal role you will be the strategic regulatory voice across Project Teams defining global regulatory strategies for innovative medicinesincluding small molecules biologics and radiopharmaceuticalsfrom 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.

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:Managecoachand contribute to the development ofjunior regulatory team members.

Profile Required

• Educational Foundation: Bachelors degree in life sciences; a Masters 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 arent just values theyre 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 youll 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 Workablecheck your spam folder for emails from *@.

Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.