• Serve as the compliance lead and point of contact for one or more issuing banks, building subject matter expertise on their regulatory expectations, contractual obligations, risk tolerance, and oversight practices • Manage the day-to-day compliance relationship with bank partner counterparts, including participating in regular check-ins, preparing responses to bank inquiries, and coordinating audit and exam readiness • Act as the DRI to internal stakeholders and assigned programs to interpret, operationalize, and monitor compliance with bank-specific and regulatory requirements • Partner cross-functionally with Legal, Risk, Product, Customer Support, Bank Partnerships, and GTM teams to ensure new program product launches, marketing campaigns, and operations align with bank expectations and consumer compliance requirements • Act as a strategic advisor on compliance issues, audit findings, and regulatory developments that impact assigned banks and programs • Collaborate with Legal, Compliance, Customer Support, and other relevant stakeholders to ensure timely and effective issue remediation, including root cause analysis and implementation of sustainable controls • Support the onboarding and ongoing management and oversight of programs with assigned banks (e.g., supporting due diligence reviews, periodic site visits, advising on appropriate risk mitigation measures and controls, etc) • Help develop and refine internal policies, procedures, controls, and playbooks to ensure consistent application of regulatory and partner bank requirements across programs

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.

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 a Senior Director on the Regulatory Affairs, Gene Therapy team to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs, Gene Therapy you’ll serve as the regulatory lead at the Global Project Team (GPT) for assigned program(s). You may also serve as the regulatory lead at the sub team level, as needed, to support business needs. This role can be onsite, hybrid or remote. What You'll Do: In this role, in collaboration with the VP and program lead, you’ll have the opportunity to define, develop, and implement a well-defined global regulatory strategy plan to facilitate efficient and competitive product development from early to late-stage development through registration and life-cycle management. You’ll also: - Provide expert analysis and strategic guidance on regulatory risks, pathways, and policy shifts to ensure program objectives are met - Actively participate in cross-functional decision-making discussions to ensure potential regulatory impact on product development and lifecycle management are communicated and considered - Proactively identify and communicate potential risks and define mitigation strategy to prevent, or minimize, their impact to assigned program(s) - Lead overall strategy and preparation of key regulatory dossiers including, but not limited to, meeting requests, briefing documents, Orphan drug applications, INDs, CTA/CTRs, CTNs, and applications for expedited pathways (fast track, RMAT, etc.) as needed - Lead monthly Global Regulatory Team meeting - Present regulatory strategy at cross-functional team meetings and to senior leadership, upon request - Monitor the evolving regulatory competitive landscape to identify potential opportunities and areas of risk to assigned programs - Interpret complex regulatory regulations/guidance’s to inform development plans and potential impact to key stakeholders - In concert with the regulatory policy lead, influence regulatory environment via commenting on draft guidance’s of direct interest to Insmed’s gene therapy portfolio - Regulatory technical writing and review of documentation prepared by other technical functions (nonclinical, clinical and CMC) supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements - Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines - Ensure accurate archiving of correspondence and submissions, and manage vendor/consultant roles, where applicable. - Serve as the primary contact with FDA, guide and/or lead complex interactions with regulatory and health agencies (e.g., FDA) on critical regulatory matters - Mentor junior regulatory professionals and support a culture of continuous learning, cross-training, and operational excellence. - In partnership with assigned regulatory lead and regulatory operations, and/or third-party service providers, ensure high quality, complaint, on-time submission activities related to initial regulatory filings and application maintenance e.g., IND/CTA/CTR, information amendments, SAE reports, etc.) Who You Are: You have a Bachelor’s degree along with 12 years of experience in Regulatory Affairs, and/or relevant product development experience in the pharmaceutical or biotechnology industry. You are or you also have: - 5+ years of gene therapy orphan (rare) drug development experience - Strong leader and strategic thinker with prior experience in the development and execution of global drug development of gene therapies for orphan (rare) diseases ideally in both early and late phase development - Prior experience serving as a Global regulatory lead on a multi-functional cross functional development team - Proven ability to influence/inform cross functional teams on potential regulatory risks of strategic decisions and provide sound regulatory guidance to ensure program and company objectives are met - Experience in partnering with Regional regulatory leads to ensure local regulatory planning and strategy aligns and supports the Global development strategy - In-depth knowledge and direct application of US/EU/Japan/International regulations and ICH guidance documents pertaining to gene therapy product development - Strong working knowledge and experience with electronic submissions (eCTD) - Experienced in the submission and management of IND/CTA/CTRs and global registration applications (e.g., BLA, J-NDA, and MAA); post approval life cycle management - Experience in leading direct interactions with Health Authorities at key milestone meetings and on complex regulatory matters - Strong team player with ability to effectively collaborate across multiple functional areas - Proven ability to manage multiple priorities simultaneously in a fast-paced, growing organization - Excellent communication skills (verbal and written) - Strong attention to detail, clarity, accuracy, and conciseness Nice to have (but not required): - Master's/PhD/PharmD - RAC certification - Knowledge of neurology and/or ophthalmology drug development and regulation of medical devices Where You’ll Work This role can either be onsite, hybrid or remote. 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 travel (approximately 25%) #LI-REMOTE #LI-MC1 Pay Range: $222,000.00-303,000.00 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.

Job DetailsJob Location: New York, NY 10004Benchmarking and Compliance Intern Location: New York, NY or Remote Paid Internship: $20/hr Bright Power has been a transformative player in clean energy and sustainable buildings since 2004. We believe a meaningful difference in climate change will only be realized if it is easy for building owners to make their buildings better. Our approach is simple: we find energy and water problems in buildings, we fix them, and we follow up to make sure the solutions worked. Behind the scenes, our unique combination of software, analytics, engineering, and contracting makes it all happen. If you have a can-do problem-solving attitude and are excited to join a company of the brightest minds working on energy and water in buildings, then apply to join our team! Join Us Bright Power is comprised of a team of diverse, talented, and hard-working individuals committed to growing this industry and making a positive impact on the environment. We are passionate about reducing energy and water usage by implementing energy efficiency and renewable energy technologies. Our goal is to improve the health, comfort, and value of our client’s buildings, while cultivating a sustainable future. We believe deeply in doing well by doing good and come to work every day seeking to change the world. The Role The Analysis Business Unit of Bright Power is seeking detail-oriented and motivated interns to join our team. Bright Power works with property owners who have loans through the Fannie Mae Green Loan program and helps them meet their utility data reporting requirements. The Benchmarking and Compliance Intern will review and integrate property owner-paid utility data, as well as research, review, and request whole-building or individual apartment authorization forms and utility data. This position plays a crucial role in ensuring the success of the entire program. Primary Responsibilities Conduct quality assurance of utility data sources and authorizations from external clients Prepare, transfer and store documents to ensure high standard of accuracy and organization Troubleshoot and communicate issues relating to data access and quality Ensure accurate and efficient integration of utility account data into our systems Communicate with utility companies to submit documents, request tenant data, and troubleshoot ongoing requests Research utility companies’ policies for data release Collaborate with team members to improve workflow processes Contribute to other projects as needed QualificationsSkills/Qualifications Clear written and verbal communication Strong attention to detail Analytical and problem-solving skills Experience with spreadsheet-based programs -- Microsoft Excel or Google Sheets Comfortable speaking on the phone and writing emails to external parties Self-motivated and self-organizing direction -- this position works with an end deliverable for a client that has many moving pieces Ability to work well in a team-oriented environment providing ideas and open feedback Preferred Qualifications Candidates with a bachelor’s degree in science, engineering or similar technical field are preferred Experience in the real estate, energy efficiency, renewable energy, sustainability or building operations world Experience with utility bill data Intermediate knowledge of Excel Experience with cloud-based CRM platforms -- Salesforce Experience with Energy Star Portfolio Manager, especially for multifamily buildings What you get out of working at Bright Power Opportunity to learn about energy management, working with utilities and utility data, and sustainable buildings Full-time position at $20 hourly salary Training in utility benchmarking and industry-standard software tools Networking with leaders across Bright Power’s business units, and connections to leaders in the building and energy industry 8 hours of paid time off per month Be part of a team that is hard-working and driven, but doesn’t take itself too seriously Equal Employment Opportunities Bright Power provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Bright Power complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Bright Power expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Bright Power’s employees to perform their job duties may result in discipline up to and including discharge.