Regulatory Affairs Specialist

At Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .At Johnson Johnson, we provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function:QualityJob Sub Function:Quality SystemsJob Category:ProfessionalAll Job Posting Locations:Schaffhausen, SwitzerlandJob Description:We are searching for the best talent for a Regulatory Affairs Specialist.Location:Schaffhausen, SwitzerlandContract Type:Temporary full-time position (2-year contract)PurposeWe are looking for a Regulatory Affairs Specialist to join our team in Schaffhausen, Switzerland.In this role, you will provide regulatory support to the Schaffhausen manufacturing site and help ensure compliance with Swiss and international regulatory requirements. Acting as a key point of contact for regulatory activities, you will support health authority interactions, lifecycle management activities, regulatory documentation, and site projects that are critical to maintaining compliance and continuity of supply.Working closely with local site functions, Global Regulatory Affairs, and health authorities, you will help ensure timely execution of regulatory commitments and effective management of regulatory requirements across the site.You will be responsible forIn this role, you will serve as a primary Regulatory Affairs contact for site-related regulatory activities and support interactions with Swissmedic and other health authorities.You will coordinate regulatory documentation, support lifecycle management activities, and provide regulatory guidance for site projects and manufacturing changes. The role also includes helping ensure regulatory commitments are met and that site activities remain aligned with applicable regulatory requirements.Key responsibilities include:Acting as a primary Regulatory Affairs contact for site-related interactions with Swissmedic and other health authoritiesPreparing, submitting, and managing Swissmedic Major Change Notifications and other regulatory communicationsCoordinating, preparing, maintaining, and issuing regulatory documentation, including:Certificates of Pharmaceutical Product (CPPs) for Switzerland and EU marketsGMP CertificatesManufacturing LicensesRegulatory declarations and statementsCountry-specific regulatory documentsManaging direct correspondence with Swissmedic regarding CPP requests, GMP Certificates, Manufacturing Licenses, regulatory inquiries, and site-related activitiesCoordinating responses to regulatory requests from Health Authorities, Local Operating Companies, and Global Regulatory Affairs organizationsSupporting regulatory assessments of change controls, site projects, manufacturing changes, and business initiativesParticipating as the Regulatory Affairs representative in strategic site projects and health authority interactionsMaintaining and supporting site regulatory documentation, including Site Master File updates, Major Change tracking, and regulatory databasesProviding regulatory guidance to site functions and helping improve regulatory awareness through training, job aids, and compliance initiativesContributing to initiatives that strengthen regulatory compliance, efficiency, and regulatory processesQualifications / RequirementsWe are looking for someone who combines regulatory knowledge, strong organizational skills, and the ability to work effectively across a regulated manufacturing environment.EducationBachelor's or Master's degree in Pharmacy, Chemistry, Biology, Engineering, Life Sciences, or another relevant scientific fieldExperienceMinimum 4 years of experience in the pharmaceutical industry within Regulatory Affairs, Quality, Compliance, Manufacturing, or another GMP-regulated environmentExperience coordinating regulatory documentation and supporting regulatory submissionsKnowledge SkillsKnowledge of GMP requirements and pharmaceutical manufacturing processesStrong organizational skills with the ability to manage multiple priorities and deadlinesStrong stakeholder engagement and cross-functional collaboration skillsAbility to work independently while maintaining a compliance-focused approachStrong communication and interpersonal skillsHigh attention to detail and quality mentalityAbility to influence and collaborate across functionsStrong sense of ownership and accountabilityContinuous improvement approachAbility to prioritize effectively in a dynamic environmentPreferred QualificationsExperience interacting directly with Health Authorities, preferably SwissmedicExperience managing Certificates of Pharmaceutical Product (CPPs), GMP Certificates, Manufacturing Licenses, or regulatory authority requestsExperience supporting Change Control processes and regulatory impact assessmentsLanguage RequirementsFluent English and German, both written and spokenAbility to communicate effectively with local authorities and Global Regulatory Affairs organizationsStrong written communication skills for preparation of regulatory correspondence, submissions, and health authority responsesDemonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivityWhat we offerWe offer a collaborative and inclusive environment where learning, innovation, and professional development are encouraged.In this role, you will have the opportunity to work closely with manufacturing, quality, and regulatory teams while supporting regulatory activities that contribute to the reliable supply of products to patients across global markets.Our commitment to inclusionAt Johnson Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.#LI-HybridPreferred Skills:Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People #J-18808-Ljbffr