Associate Director, Regulatory Affairs EMEA - Selected Projects

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for four consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we’re in. Are you?This role can be located in either Switzerland or the United Kingdom. About The RoleEMEA Regulatory Lead for Selected ProjectsEMEA Regulatory strategy, tactical regulatory implementation and regulatory activities for selected projects, in alignment with the Head of EMEA Regulatory Affairs, GRLs, Global stakeholders and the EMEA businessRegulatory Lead for selected projects for clinical trials outside of North America and Japan, including but not limited to the EU CTRRepresentation of EMEA RA for selected projects at GCTs, GRTs and assigned multifunctional teamsWhat You'll DoDevelop Regulatory Strategy for selected projects for EMEA Region, closely integrated with the Global Regulatory Strategy, Global Projects and the EMEA BusinessRepresentation EMEA Regulatory Affairs in Regional and Global Fora, interfacing with regulatory and multifunctional stakeholders, as to ensure overall product/project alignment for designated areasDevelopment, management and implementation of Regulatory plans for selected projects for EMEA RegionCommunicate regulatory requirements to ensure optimal execution of the regulatory activities for selected projects in EMEA RegionLead development and submission of briefing packages to Regulatory Agencies in the EMEA Region for selected projects, e.g. but not limited to Requests for Scientific Advice, PIP Submissions, Meetings with the Agencies.Lead eventual development of MAAs and post approval Variations in EMEA region for selected projectsEMEA Regulatory Lead for clinical trials on selected project outside of North America and Japan, including but not limited to the EU CTRWho You AreExperience and Education:8+ years of experience and broad knowledge in the field of pharmaceutical Regulatory AffairsTrack record of contributing to and implementation of Regulatory StrategyExperience with planning, preparing, and filing original applications, Variation submissionsGood understanding of the EMEA and MHRA regulatory landscape, especially Health Authority regulations, guidance documents, processes, and timelinesBachelor’s degree in Life SciencesUp to 10% travelSkillsTeam player with the ability to successfully collaborate and partner in a dynamic and culturally diverse workplace.Strategic mindsetExcellent communication skills (verbal and written) .Proficient in EnglishHighly organized with a strong attention to detail, clarity, accuracy and concisenessCritical ThinkingAbility ToUnderstand, identify, and act by the Insmed 5 values: Collaboration, Accountability, Passion, Respect, and IntegrityListen to and value others’ thoughts and ideas.Demonstrate self-awareness, humility, and curiosity in service of self-development.Embrace diversity and strive for inclusion and belongingAbility to work in a growing, fast-changing environmentLife at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.Our Offerings IncludeFlexible work schedules with purposeful in-person collaborationCompetitive retirement benefits, global equity awards, and participation in our Employee Stock Purchase Plan (ESPP)Career development through the Insmed Learning Institute, external programs, LinkedIn Learning, and role-specific trainingAI-powered and on-demand learning tools, including a digital assistant to help navigate internal resourcesHybrid-friendly technology and IT support for seamless teamwork across locations and time zonesGlobal recognition programs and Employee Resource GroupsEligibility for specific programs may vary and is subject to the terms and conditions of each plan. Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.Applications are accepted for 5 calendar days from the date posted or until the position is filled.