For companies:
For professionals:
For everyone:
For developers:
Responsibilities
About The RoleWe’re looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead – Development Strategy on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Affairs, you’ll be responsible for formulating and implementing global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. You will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA. The GRL will be accountable for regulatory submissions, communications, and negotiations with global Health Authorities for designated products.What You'll Do’ll have the opportunity to Lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs. You’ll also:Identify and assess regulatory risks associated with product development and define risk-mitigation strategiesProvide regulatory guidance across functions throughout the R&D process and advise on the US IND and global CTA submission strategiesDirect the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing applicationsOversee the organization and preparation of clear, concise, and effective regulatory submissionsProvide oversight for preparation and delivery of materials for regulatory agency meetingsPrepare and deliver high-quality presentations for both internal and external audiencesMonitor, evaluate, and interpret global regulatory agency activities in relevant areas; assess potential impact on company programsLead effectively in a matrix environment, collaborating with regional regulatory leads and cross-functional teamsWho You AreYou have a Bachelor’s degree in life sciences or related field along with 8+ years of experience h hands-on experience in regulatory submissions across multiple regions (US, EU, and/or other international markets).You Are Or You Also HaveStrong knowledge of global regulatory requirements and submission formats (eCTD)Proven experience managing complex regulatory deliverables across product lifecycle stagesStrong submission writing and review skills are essentialSignificant experience , and other global regulatory agenciesDeep understanding of the drug development processHighly organized with strong attention to detail, accuracy, clarity, and concisenessAbility to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starterNice To Have (but Not Required)Advanced degree (MS, PhD, PharmD) strongly preferredExperience with orphan drug products is highly preferredExperience with inhalation products a plusWhere You’ll WorkThis is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.Travel RequirementsThis role requires occasional domestic/international/global travel (approximately 20%)Life at InsmedAt 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.Highlights Of Our U.S. Offerings IncludeComprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insuranceCompany Learning Institute providing access to Linkedll building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give backEligibility for specific programs may vary and is subject to the terms and conditions of each plan.
This job post is closed.