Job Description

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. and a place on The Sunday Times Best Places to Work list in the UK. We’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, Head of Regulatory Strategy and Implementation, you’ll be responsible for formulating and implementing 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 regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA. You will be accountable for regulatory submissions, communications, and negotiations with FDA for designated products. In this role, you’ll have the opportunity to Lead development and execution of regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs. Identify and assess regulatory risks associated with product development and define risk-mitigation strategies Provide regulatory guidance across functions throughout the R&D process and advise on the US IND, NDAs or BLAs and global CTA submission strategies Direct the planning and coordination of regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing applications Oversee the organization and preparation of clear, concise, and effective regulatory submissions Provide oversight for preparation and delivery of materials for regulatory agency meetings Prepare and deliver high-quality presentations for both internal and external audiences Monitor, evaluate, and interpret global regulatory agency activities in relevant areas; Work effectively in a matrix environment, collaborating with GRL and other regulatory regional leads and cross-functional teams, You hold a Bachelor’s degree in life sciences or related field along with 8+ years of experience in Regulatory Affairs is required (advanced degree (MS, PhD, MD, PharmD) is preferred) with hands-on experience in regulatory submissions. Strong knowledge of global regulatory requirements and submission formats (eCTD) Proven experience managing complex regulatory deliverables across product lifecycle stages Strong submission writing and review skills are essential Significant experience in interactions with FDA, and other global regulatory agencies This 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 Requirements This role requires occasional domestic/international/global travel (approximately 20%) #LI-Remote 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. Comprehensive 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 collaboration
• 401(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 insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Please apply via the Jobs Hub in Workday.

We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site. An employer who violates this law shall be subject to criminal penalties and civil liability. 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.Applications are accepted for 5 calendar days from the date posted or until the position is filled. If you'd like guidance on recognizing potential recruitment fraud, please reach out to recruitmentfraud@insmed.

Job Tags

Local area, Remote work, Flexible hours

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