Senior Expert Regulatory Affairs – Biosimilars

At
Polpharma Biologics Switzerland AG
, we are building something different – a biosimilar company defined by purpose, speed, and people. We own the full value chain, from product selection to global launch, making high-quality biologics more accessible worldwide. We are looking for a
Senior Expert Regulatory Affairs – Biosimilars
to join our lean, empowered, cross-functional team. You will drive excellence across the full development lifecycle, from early clinical planning to market authorization – and even beyond If you are passionate about innovation, compliance, and making a global impact, this is your moment.

Your responsibilities include, but are not limited to:

• Serve as key regulatory expert for global biosimilar strategies, identifying gaps and risks, driving operational execution, and aligning on regulatory aspects with internal teams and external partners (e.g. CROs, C(D)MOs, consultants, business development partners) to drive success.
• Lead or contribute to regulatory submissions (e.g. briefing books, CTAs, INDs, MAAs, BLAs, variations), ensuring timely delivery and compliant responses to HA requests.
• Define requirements and set objectives for Health Authority (HA) interactions in collaboration with relevant stakeholders
• Review and guide clinical documentation (e.g. protocols, reports, informed consent forms, investigator brochures) to ensure regulatory alignment and scientific integrity.
• Review and guide CMC & device related documentation, define and lead CMC regulatory strategy and making risk-balanced decisions.
• Prepare for and lead HA meetings, including scientific advice and pre-submission briefings, crafting strategic responses and briefing materials.
• Monitor regulatory trends and competitor activity, translating insights into actionable strategies for biosimilar development.
• Support regulatory operations and compliance, contributing to SOPs, inspection readiness, and cross-functional capability building.

What you bring:

• MSc or PhD in biotechnology, biochemistry, biology, or related field.
• 7+ years of experience in regulatory affairs, with a focus on biologics/monoclonal antibodies (biosimilars preferred).
• Strong knowledge of regulatory procedures in highly regulatory markets, including US (FDA) and EU (EMA),, with hands on experience in eCTD publishing.
• Experience with clinical and CMC related regulatory documentation and regulatory submissions in EU, US and other markets, covering development and commercial phases.
• Excellent communication, planning, and organizational skills.
• A collaborative mindset and ability to thrive in a matrix organization.

What we offer:

At Polpharma Biologics Switzerland, we believe in working with care — for patients, partners, and each other. We empower every team member to own their work, unlock their potential, and shape the future of biosimilars with purpose. To support your well-being, growth, and sense of meaning, we offer a comprehensive range of benefits, including:

• Competitive package with base salary, bonus and fringe benefits.
• Attractive pension plan with preferential savings and risk components.
• Hybrid workplace model, with a nice office in Zug/Switzerland and home-office possibility.
• An empowered team that enjoys driving our business forward together, and celebrates shared wins.
• A purposeful industry association where we enlarge the access for patients in need with affordable solutions.