(Senior) Manager, Drug Regulatory Affairs 80-100%

Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need.Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:(Senior) Manager, Drug Regulatory Affairs 80-100%Scope of WorkThe Senior Manager, Drug Regulatory Affairs, is responsible for leading a range of global regulatory activities, encompassing both strategic and operational responsibilities across drug development, registration, and post-marketing phases. This role offers the opportunity to work in close collaboration with key cross-functional teams — including Clinical Operations, Clinical Sciences, Pharmacovigilance, Biostatistics, Preclinical and CMC, as well as Marketing and Commercial.Please note: We are considering both Manager and Senior Manager levels for this position, depending on the candidate’s experience.Key ResponsibilitiesAnticipating, planning and driving post-approval procedures: Preparation of regulatory documents, ensuring quality and accuracy, coordinating cross-functional input, and leading submissions, including variations/extensions, PAMs, renewals, scientific advice and meetings with health authorities, and acting as the main HA regulatory contact point.Global expansion of Agamree: Serving as contact point for local partners and representing DRA in operational tasks for new markets; providing regulatory support for filings in RoW countries; managing post-approval activities in collaboration with local partners.Regulatory Intelligence: Identifying and monitoring relevant guidance, regulations, and sources to ensure ongoing regulatory compliance.Providing cross-functional support as required: Supporting Safety and Pharmacovigilance (PSURs, DSURs, PASS, RMP, etc.), Clinical Science/Operations, Quality Assurance, Supply Chain, and Commercial (review of promotional/non-promotional materials, market launch), and participating in due diligence activities.Critical review of documents: Ensuring accuracy, scientific validity, and optimal presentation of key documents such as IBs, protocols, and IMPDs.Document management: Filing and archiving regulatory documents per SOPs and maintaining electronic filing systems and internal regulatory archives.Clinical Trial Authorisation applications and maintenance: Preparing and submitting clinical trial applications and amendments, managing trial notifications, contributing to clinical trial strategy decisions, supervising regulatory CRO counterparts, liaising with regulatory authorities, supporting the Study Management Team with regulatory guidance, and assisting DS&PV with DSUR preparation and submission.Required Qualifications & ExperienceA minimum of 5 years of experience in Drug Regulatory Affairs in a pharmaceutical company or CROA minimum of a master’s degree in life sciencesKnowledge of CH, EU and international regulationsPrevious experience in operating within complex matrix organizationsFluency in English, both written and oralKnowledge of German and other languages would be an assetRequired Competencies & SkillsExcellent communication, interpersonal and networking skills Self-motivation, personal resilience, perseverance, energy and driveAbility to work independently and collaboratively, as required, in a matrix organization Excellent planning and organizing skillsFlexibility in adapting to changing priorities and deadlinesCapable of dealing with ambiguity, risk taking and decision making in a fast-paced entrepreneurial environmentOpen minded, solution oriented For this position, the relevant working/residency permit or Swiss/EU-citizenship is required.If you are interested in a fast-paced, multicultural, challenging, and innovative working environment and your profile matches our requirements, we are looking forward to receiving your online application in English via LinkedIn or email, at career@santhera.comNote for agencies: Recruitment agencies are kindly invited to refrain from sending unsolicited CVs to Santhera.