(Senior) Regulatory Affairs Manager
vor 1 Monat
Access – Providing high quality trusted medicines regardless of geography or circumstance;Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.The Role & What You Will Be DoingEvery day, we rise to the challenge to make a difference and here’s how the (Senior) Regulatory Affairs Manager (m/f/d) role will make an impact:Timely submissions and execution of assigned products portfolio and other projects including full products lifecycle and new products submissions for Switzerlandlnteracting with various stakeholders on a local and regional level (Global Regulatory Affairs, Global Labelling, Quality, Supply Chain, Pharmacovigilance and Commercial) and the Regulatory AuthorityMonitoring regulatory trends and provides strategic input to the managementStaying updated with local regulatory requirements and processes and the authority organizationAdhering to local processes and procedures to ensure clear regulatory responsibilities within the affiliate in line with Global SOPs and local regulationsSupporting both internal regulatory audits and Regulatory Authority inspections, and ensures that any corrective actions are completed according to scheduleAbout Your Skills & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Master’s Degree in life sciences5 years of professional experience in Swiss Regulatory Affairs related to pharmaceutical productsFunctional understanding of the pharmaceutical industryFamiliarity of local Swiss regulation for OTC products, Medical devices, cosmetics and food supplements and knowledge of regulatory requirements (e.g. revised Medical Device Ordinance / MDR) are benefitsExperience as PRRC is an advantageKnowledge of the national and EU regulations, regulatory guidance, policies, and proceduresGood planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholdersExcellent communication skills in German and English (written and oral)At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.Benefits at ViatrisAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:Friendly working atmosphere in a great team, Great Place to Work certified officeHome office option up to 3 days per weekDevelopment opportunities within an international companyDiversity & Inclusion at ViatrisAt Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit Sustainability at ViatrisCorporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. SummaryLocation: Zug, Zug, SwitzerlandType: Full time
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