Head Regulatory Affairs, Switzerland Zurich, Canton of Zurich Category: Regulatory Affairs

Job description

Head Regulatory Affairs, Switzerland Zurich, Canton of Zurich Apply Now Job ID R0193842 Category Regulatory Affairs Subcategory Research & Development Business Unit Research & Development Job Type Full time By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role The Regulatory Affairs Country Head, Switzerland leads the Swiss Local Operating Company (LOC) Regulatory Affairs function and ensures timely, compliant, and business-relevant regulatory support for products marketed in Switzerland and Liechtenstein. The role partners closely with the Group Head, Regulatory Affairs – Central Europe to align Swiss priorities, regulatory strategy, resource planning, risk escalation, and regional governance. The role also collaborates with Commercial, Medical, Quality, Pharmacovigilance, Market Access, Supply Chain, Development, and global and regional Regulatory Affairs teams. Activities involving Plasma-Derived Therapies require close collaboration with the Plasma-Derived Therapies Regulatory organization. The role provides strategic and operational regulatory leadership across the product lifecycle, from development and registration through launch, post-approval maintenance, lifecycle management, and supply continuity. How you will contribute • Lead the Swiss Regulatory Affairs function, setting clear priorities and ensuring consistent, effective, compliant, and patient-focused delivery. • Partner closely with the Group Head, Regulatory Affairs – Central Europe to align Swiss priorities, regulatory strategy, resource planning, risk escalation, and regional governance. • Develop and execute Swiss regulatory strategies for new marketing authorization applications, new indications, line extensions, significant product changes, and lifecycle-management activities. • Secure and maintain Swiss marketing authorizations through national, reliance, and other applicable procedures, ensuring submissions, commitments, and post-approval activities are accurate, timely, and compliant. • Provide strategic regulatory advice to Commercial, Medical, Quality, Pharmacovigilance, Market Access, Supply Chain, Development, and global and regional Regulatory Affairs stakeholders. • Enable product development, registration, launch, lifecycle management, and supply continuity in Switzerland and Liechtenstein by anticipating, assessing, communicating, and mitigating regulatory risks. • Maintain effective relationships with Swissmedic and other relevant health authorities, including leading responses to authority questions and resolving procedural or technical issues. • Represent the Swiss LOC in global, regional, and local regulatory governance and decision-making forums. • Monitor Swiss and relevant international legislation, guidance, regulatory intelligence, and emerging expectations, and translate developments into clear business implications and actions. • Ensure regulatory records, systems, processes, and documentation are accurate, complete, controlled, and inspection-ready. • Build an inclusive, collaborative, and high-performing team; strengthen capabilities and succession; and manage the departmental budget, contracts, purchase orders, and invoice approvals in line with Takeda policies. Skills and Qualifications • Bachelor’s or advanced degree in life sciences, pharmacy, medicine, chemistry, or a related discipline. • At least 10 years of Regulatory Affairs experience in the pharmaceutical, biotechnology, or healthcare industry, including substantial experience with Swiss regulatory requirements and procedures. • Demonstrated experience leading a small- to medium-sized Regulatory Affairs team or supervising colleagues with different levels of experience. • Proven ability to lead multiple complex regulatory projects, manage competing priorities, and make sound decisions in a matrixed environment. • Hands-on experience preparing, reviewing, and submitting Swiss marketing authorization applications and post-approval submissions, including variations, renewals, safety-related submissions, commitments, and periodic safety activities. • Experience developing regulatory strategies for new marketing authorization applications, new indications, line extensions, and significant product changes. • Experience preparing, reviewing, and maintaining product information, labeling, and packaging materials. • Experience interacting with Swissmedic or other relevant health authorities, including responding to questions and resolving procedural or technical issues. • Experience providing regulatory input to cross-functional development, launch, supply, safety, market access, medical, and commercial activities. • Proficiency with electronic regulatory tracking databases, document-management systems, and submission-management tools. • Experience maintaining inspection readiness and supporting audits or regulatory inspections. • Strong written and verbal communication skills in English and German. Italian and/or French language is an advantage. • Strong stakeholder-management, influencing, prioritization, and problem-solving skills, with the ability to operate autonomously and collaborate effectively in a multinational, culturally diverse organization. • Demonstrated commitment to inclusion, ethical conduct, compliance, and Takeda’s patient-focused culture. Locations Zurich, Switzerland Base Salary Range: CHF159,300.00 - CHF219,010.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. For information about our benefits, please click here . 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