• Responsible for managing compliance processes, including the preparation, communication, implementation, and monitoring of adherence to policies and standards to promote compliance with legal and regulatory requirements • Research applicable compliance requirements • Provides compliance advice and support to the Company, its subsidiaries, and affiliates • Assists with follow-up through resolution of due diligence findings relating to acquisitions and investments, marketing and transparency law compliance (national, state, and international); government contracting and government-funded entity compliance;and other compliance projects also within position scope as needed • Follows up on implementation of compliance recommendations, including as a result of due diligence findings for acquisitions and investments • Assists with risk assessments, works with internal/external audit to review program compliance, and utilizes analytics tools and other methods to monitor compliance, identify potential areas of risk, and prioritize risk resolution • Becomes familiar with federal, state, and global legal/regulatory requirements and timely responds to field/client questions • Marketing and sales materials and programs review • Works with Sunshine systems analyst and analytics tool to understand business activity trends and outliers, and advises on compliance implications under Sunshine • Follows up on implementation of compliance recommendations and documentation/records of disclosures in invoices, marketing materials, terms and conditions, Privileges program, websites, etc. • Reviews and prepares legal documentation related to Sunshine- contracts review, forms supporting reporting, etc. • Maintains a library of Sunshine forms and provides them to operations for consistency • Keeps the Sunshine Assumptions document current to support our reporting interpretations • Assists with dispute resolution procedures/advise on the process • Donations Review– assists with new policy development, review of structures, and monitoring • Government contracting and government-funded entity compliance • Monitors new CMS interpretations of Sunshine requirements • Publish periodic FAQs/field communications as appropriate • Formalizes state policies for states with similar transparency or other marketing compliance requirements; roll out as applicable • Assures applicable annual reporting requirements and periodic training requirements are met (state, federal, and international) • Monitors new global transparency and relevant marketing requirements (e.g., France, others proposed e.g,. Australia) • Creates guidelines, tools, and advises global operations to ensure compliance • Assists with other compliance work as needed (may involve international work)

• Lead the compliance program to develop, implement, and own the overall compliance strategy, positioning compliance as a core value and top priority at Cristcot. • Establish and own company-wide SOPs and policies, enabling best practices across the organization that cover promotional review, scientific/educational activities, field operations, contracting, and more. • Own and strategically lead MLR/PRC processes: Oversee end-to-end MLR workflow Chair/co-chair PRC meetings; ensure efficient support for both promotional (sales/marketing) and non-promotional/scientific/educational materials. • Design and deliver targeted compliance training & education for Commercial and Medical teams. • Provide compliance oversight for market access and contracting: Lead review and risk mitigation for payer agreements, rebate contracts, pricing programs, and government program compliance (e.g., Medicaid Best Price, AMP calculations, transparency reporting), including red-flag screening and documentation. • Drive risk management, monitoring, and continuous improvement Monitor regulatory landscape and lead adaptations: Stay ahead of FDA (OPDP), CMS, PhRMA, DOJ, and other guidance; proactively update SOPs, processes, and training to maintain compliance in a dynamic environment. • Lead investigations and audit readiness inclusive of overseeing deviation investigations, root-cause analysis, corrective/preventive actions; maintain audit-ready records for MLR, contracts, training, field activities, and rebates/payments; support audits/inquiries. • Serve as strategic advisor and cross-functional partner with business-oriented compliance guidance to senior leaders and teams; collaborate to align priorities, enable compliant innovation, and foster ethical decision-making across the organization.

• Provide authoritative interpretation of applicable codes and standards and translate requirements into clear, actionable guidance for cross-functional engineering teams. • Serve as a lead technical resource to R&D, Product Engineering, Quality, Supply Chain and Manufacturing on standards-driven design decisions and compliance pathways. • Act as the primary technical interface with UL and other NRTLs, defining certification approaches, supporting testing and evaluation activities, and maintaining product listings and certifications. • Collaborate with engineering teams to ensure new product designs, design changes, and component substitutions align with applicable standards and certification requirements, supporting continuity of supply. • Interpret changes to codes and standards, assess applicability to IEM products, and provide recommendations, training, and reference materials to compliance leadership and other stakeholders as needed. • Develop training and educational materials related to codes and standards for internal and external teams as needed.

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 five 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? About the Role: We’re looking for an Associate Director, Regulatory Affairs – Advertising and Promotion to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Ad Promo & Intelligence Initiatives, the Associate Director will review and approve advertising and promotional materials, related training, and other nonproduct commercial communications, medical materials, and publications. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new and updated regulations and guidance documents for both labeling and promotion. The Associate Director, Regulatory Affairs – Advertising and Promotion will also coordinate training pertaining to advertising, promotion, and product launch activities. The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for product portfolio. What You'll Do: In this role, you’ll have the opportunity to represent Regulatory Affairs as part of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials. You’ll also: - Maintain a deep and current awareness of evolving US regulations, codes and guidelines, enforcement actions, and policy issues affecting the pharmaceutical/biotech industry as it pertains to labeling and promotion. - Represent Regulatory Affairs as a reviewer on medical review committee providing regulatory input on materials that include clinical trial recruitment efforts and field medical resources. - Provide regulatory review on publications and own responsibility for ensuring compliance with regulatory agencies’ requirements. - Provide strategic regulatory advice for labeling, taking into consideration marketing use post-approval. - Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management. - Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities. Who You Are: You must have at least a Bachelor’s degree in a relevant/scientific discipline and 7+ years’ experience working in the pharmaceutical or biotech industry. Additionally, you have: - 5+ years working in the advertising and promotional review space. - Experience working with OPDP and with post market FDA submissions. - Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion. - Knowledge of US regulations for labeling. - Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions to reach resolution. - Strong writing, project management, and communication skills. - Proven ability to thrive in a fast-paced environment. - Strategic problem solver with strong collaboration skills. Nice to have (but not required): - Graduate degree preferred. - Awareness of global drug/biologic regulations and standards particularly related to promotion including EU and international requirements. Where You’ll Work This can be a fully remote role because the selected candidate should be able to perform effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Alternatively, if you live within a drivable distance of our Bridgewater, NJ facilities, you’ll have the option to work remotely most of the time, but with more in-person collaboration when it matters most. Travel Requirements This role requires domestic travel (up to 25%). #LI-MM1 #LI-Remote Pay Range: $164,000.00-213,000.00 Annual Life 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. Highlights of our U.S. offerings include: - 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 - Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.  Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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.