Regulatory Affairs Manager

Janssen-Cilag AG is looking for a Regulatory Affairs Manager based in Zug. Company Background & Culture Caring for the world, one person at a time inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products, and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world. Who is Janssen? Are you passionate about crafting a world without disease? Do you have expertise in Regulatory Affairs Switzerland? At the Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science, and creativity to discover groundbreaking medicines. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science. Role Purpose: Janssen Cilag is currently recruiting a talented Regulatory Affairs Manager located in Zug, Switzerland to lead accelerated broad patient access from a regulatory perspective for Janssen's key brands. The successful candidate will act as the local regulatory expert on the designated products. The jobholder plays a key role in the cross-functional country value teams and will report to the Lead Regulatory Affairs, who in turn reports to the Director External Affairs & Market Access. Key responsibilities include: Leading complex regulatory projects and securing an as quick as possible registration of new products and indications with the best possible outcome Maintaining the existing registration licenses through the development and execution of a regulatory strategy for each assigned regulatory drug project Handling the entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. Liaising and closely collaborating proactively with the cross-functional team including Quality Assurance, Supply, and Market Access Enabling timely approvals with advantageous wording in the product information is supported by clinical and scientific data and in accordance with regulatory guidelines and business needs Providing the most accurate pipeline planning Securing dispatch of Global dossiers within the assumed business plan timeline and ensuring preparation of a commercial business case if relevant Communicating to Global teams the Swiss specific regulatory processes and requirements Acting as a reliable and competent contact to Swissmedic for the assigned products Monitoring legal requirements for registration processes Ensure efficient compliance to local, regional and Janssen regulations, to minimize risk for the patients and Janssen business Qualifications Qualifications: Pharmaceutical or scientific university degree Significant experience (~3-5 years) in Regulatory affairs working with Swissmedic within the pharmaceutical industry and a proven track record of outstanding approvals Experience in working in Quality assurance or Market Access is a plus Reliable, positive, energized, and self-motivating personality, team player Strong communication and presentation skills with the ability to convert complex data into simple messages, diplomacy, and interpersonal adaptability Ability to adapt communication style based on audience and situation Fluency in German and English, French and Italian is a plus Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location Switzerland-Zug-Zug- Organization Janssen-Cilag Switzerland (7325) Job Function Regulatory Affairs Requisition ID 2206039674W