Title: Sr Reg Affairs Spec Location: Remote Mexico Full time Remote Join Us as a Senior Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to serve as a senior contact in providing innovative solutions, including regulatory expertise. As a Senior Regulatory Affairs Specialist, you'll interact with clients to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services. What You’ll Do: • Prepares and reviews regulatory submissions. • Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies. • Leads the development and implementation of project-specific processes for sponsors. • Collaborates extensively with other departments, regulatory consultants, and regulatory authorities. • Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications. • Provides training and guidance to junior team members as appropriate. • Participates in project launch meetings, review meetings and project team meetings. • Supports business development activities, including project budgeting/forecasting. Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Strong English language (written and oral) communication skills as well as local language where applicable • Solid attention to detail and quality as well as strong editorial/proofreading skills • Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Solid negotiation skills • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other • global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc. • Solid understanding of medical terminology, statistical concepts, and guidelines • Strong analytical, investigative and problem-solving skills • Working knowledge of budgeting and forecasting

Job Title: Healthcare Coordinator Location: 100% Remote (US Only) Compensation: $45,000-$55,000 + Full Benefits Package The Healthcare Coordinator plays a critical role in Telemedica's evolving care delivery model. This position supports the clinical readiness process for veterans seeking medical evidence for VA disability claims and lays the groundwork for expanded clinical services, including future offerings that may serve veteran family members and caregivers. Coordinators ensure timely and accurate completion of intake and documentation tasks, enabling high-quality care delivery across current and future service lines. As Telemedica advances its integrated care model, this role will be foundational in supporting multi-disciplinary coordination and clinical operations. What you will do (Immediate): - Coordinate care preparation activities, including intake form readiness and documentation tracking - Communicate with veterans to gather, verify, and clarify necessary information prior to service - Support basic billing-related tasks, including confirming payment status, collecting payments, and flagging payment issues for resolution, until full customer service transition is complete - Collect, organize, and upload medical records and supporting documents to clinical systems - Confirm appointment logistics and ensure veteran readiness ahead of scheduled services - Monitor CRM/EHR task queues and ensure timely resolution of assigned workflows - Serve as the primary point of contact for veterans navigating the intake-to-service process What you will do (Long-Term): - Contribute to the development of streamlined care coordination workflows - Support initiatives to expand services beyond medical evidence into broader care delivery for veterans and their families - Collaborate with QA, Provider Network Management, and clinical leadership to enhance service continuity and provider readiness - Participate in data-informed process improvements and clinical readiness initiatives - Serve as a resource for future clinical integration efforts, including RN-led and multidisciplinary team support What you will bring: - Strong Communicator: Able to convey complex information clearly and empathetically to patients, providers, and internal teams. - Flexible and Adaptable: Comfortable navigating evolving workflows, shifting priorities, and supporting transitional responsibilities during organizational change. - Collaborative: Works effectively across clinical, administrative, and operational teams to ensure seamless service delivery. - Innovative Problem Solver: Takes initiative to streamline processes, improve veteran experience, and adapt to challenges with a solution-oriented mindset. - Detail-Oriented: Maintains accuracy in scheduling, documentation, and intake processes to support timely, high-quality care. - Mission-Driven: Demonstrates a deep commitment to serving veterans with respect, urgency, and compassion. Required Qualifications: - 2+ years of experience in healthcare coordination, medical office support, or similar clinical operations - Strong understanding of medical documentation and patient communication - High attention to detail and ability to manage multiple cases simultaneously - Experience with CRM, EHR, or care management platforms Preferred Qualifications: - Experience in a telehealth or virtual care coordination setting - Experience in multidisciplinary medical practices - Familiarity with the VA disability process - Exposure to care delivery models or integrated clinical teams Compensation and Benefits: - Healthcare: PPO and HSA plans - Retirement: 401(k) with up to 3% employer match - Flexible Spending: Health Savings Account (HSA) and Flexible Spending Accounts (FSA) - Paid Time Off: 30 Days Paid Time Off (PTO), plus 12 paid holidays, including Christmas closure - Insurance: Short and Long-Term Disability, Life Insurance - Family & Medical Leave: Paid Parental Leave, Military Leave, and Bereavement Leave - Other Benefits: Employee discounts, Jury Duty Pay, Time-Off to Vote, and more This position is NOT APPLICABLE to residents of: Alabama, California, Colorado, Kentucky, Montana, New York, North Dakota, Ohio, Oregon, Washington, Wyoming. Telemedica is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, marital status, disability or any other basis prohibited by law.

• Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director. • Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed. • Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness). • Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches. • Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies. • Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.

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: Reporting into the Executive Director, Head of US Compliance, the Director, US Compliance – Business Partner is a key leadership position, and it's so much more than a traditional compliance role. At its heart, this position is all about partnership. You'll work hand-in-hand with a wide range of Insmed's US business functions, serving as a trusted advisor and go-to resource for compliance guidance. Whether it's collaborating with the Neuro & Other Rare Therapeutic Area Program Teams, supporting exciting business opportunities, or contributing to a variety of other innovative business programs, you'll be right at the center of the action, helping teams navigate the compliance landscape with confidence and clarity. This role also offers the opportunity to make a broader impact across the organization. If you're someone who thrives on building relationships, enjoys working across diverse teams, and is passionate about fostering a culture of integrity and accountability, this role is a fantastic opportunity to do just that, all while contributing to Insmed's mission to transform the lives of patients with serious and rare diseases. What You'll Do: In this role, you’ll have the opportunity to collaborate actively and build strong, trust-based partnerships with key internal functions and cross-functional stakeholders across the organization to ensure that Compliance is embedded as a strategic enabler throughout all stages of program development and business growth. This includes, but is not limited to: - Neuro & Other Rare Program Teams: Serve as a dedicated Compliance partner providing proactive, risk-based guidance on applicable laws, regulations, and industry standards, as the programs advance through clinical development and commercialization. Engage early and consistently to identify and address compliance considerations unique to gene therapies and rare diseases, including patient access, expand access programs, and interactions with healthcare professionals. - Other Program Teams: Extend ongoing Compliance guidance and support to other Program Teams across the organization, as assigned, serving as a trusted advisor and subject matter expert throughout the product lifecycle, from clinical trials, launch, and post-market activities. Foster a culture of compliance by proactively engaging with program stakeholders, delivering targeted training, reviewing materials, and offering practical, business-oriented solutions to complex compliance challenges. You’ll also: - Attend cross-functional team meetings, actively fostering stakeholder engagement. - Oversee the implementation of mitigation plans and processes to facilitate appropriate follow-up and close-out of compliance issues as identified by monitoring and auditing team. Provide support to the Internal Investigation Committee for Compliance related items, as needed. This may include assisting with information gathering, offering guidance on processes or compliance considerations, and collaborating with team members to help drive investigations forward in an efficient and thoughtful way. - Review materials (presentations, training materials, HCP materials, data dashboards, etc.) and other activities for functional areas as assigned. - Develop and facilitate Compliance training (e-learning and live) for functional areas assigned. - Develop, review and update Policies and SOPs both Compliance departmental and representing Compliance on functional review of SOPs. - Support a proactive approach to compliance that is focused on partnerships, prevention, and risk mitigation, develop plans and deliverables to inform relevant internal functions. - Raise awareness of the Compliance program and foster accountability for compliance within the business. - Promote a continuous improvement mindset and propose enhancements to the Compliance Program informed by industry trends and best practices. Who You Are: ​You have a minimum of a Bachelor’s Degree in a related field as well as 10+ years’ experience in US Healthcare, with significant experience in US HCC for a pharmaceutical or biotech company, including but not limited to Project Management, Learning and Training, Quality Management System, Auditing and Monitoring, Data Analytics, Policy/SOP Development, Risk Assessment and Investigations. You are or you have: - In depth knowledge and understanding of applicable HCC laws and guidance, including but not limited to OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, Anti-Kickback, False Claims Act, and US transparency laws and reporting processes. - Direct, hands-on experience working within a Gene Therapy organization that possesses a high-level familiarity with the unique compliance risks associated with this space in the U.S. business context, highly preferred. - Proven experience building, implementing, and managing an effective compliance program in a growing commercial biotech environment, ideally with experience related to product launches. - Experience in continuous improvement for compliance programs. - Demonstrated ability to work collaboratively and effectively with diverse cross-functional teams and senior leadership. - High ethical standards and a proven track record of integrity and sound judgement. Nice to have (but not required) - HCC Certifications. Travel Requirements This role requires occasional travel (approximately 5%–15%). #remote #LI-EG1 Pay Range: $185,000.00-252,500.00 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. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: - A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or - An alternative selection process by emailing Privacy@insmed.com. - Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.