• 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.

• Monitor and analyze regulations/standards that apply to the compliance program for EverHealth’s electronic health record, practice management, revenue cycle management, unified communications, and document management solutions (AKS, FCA, Cures Act, HIPAA, ONC certification requirements, and information blocking rules). • Educate stakeholders about compliance and certification-related business changes. • Proactively identify and quickly analyze / communicate risks or regulatory changes to the Head of Compliance. • Maintain and utilize deep industry knowledge to drive decision-making to safeguard EverHealth and protect revenue. • Define and coordinate compliance related development projects and procedural changes • Coordinate Business Associate Agreements (tracking, templates) • Coordinate privacy & security incident management • Maintain library of compliance related implementation guides, specifications, & regulations • Develop, update, and implement security policies, standards, and procedures, ensuring alignment with regulations. • Assist with risk assessments, track vulnerabilities, manage risk registers, and oversee remediation of identified gaps. • Prepare, organize, and maintain audit-ready documentation and evidence. • Assist with the development of compliance training. • Work with business units to track progress and resolve issues. • Review security questionnaire requests and ensure vendor contracts meet security benchmarks. • Assist with security incidents, investigations, and recovery

• Analyze, review, and respond to regulatory complaints to ensure accurate, timely, and compliant resolutions. • Collaborate with cross-functional teams to enhance the complaints management process, aligning with regulatory requirements and best practices. • Conduct root cause analysis of complaints to identify trends and areas for improvement. • Develop and implement internal controls to mitigate compliance risks. • Monitor adherence to policies and procedures and test the effectiveness of processes and controls to identify potential areas of weakness. • Assist with the implementation of corrective actions to address identified issues. • Enhance existing compliance and risk management programs by evaluating regulations for applicability to our products and services and helping develop creative and compliant processes and controls. • Execute projects accurately within timeframes allotted while working collaboratively across multiple lines of business. • Conduct routine to complex fraud investigations, applying professional judgment to analyze and resolve cases efficiently. • Investigate and process Regulation Z/E claims (ACH/Card Disputes). • Execute Visa chargeback processes effectively. • Conduct informational and admission-seeking interviews with stakeholders including victims, witnesses, or suspects. • Monitor and analyze financial transactions to proactively identify and mitigate fraud risks. • Balance customer experience with risk management practices.