Senior Associate - Regulatory Affairs remote type Remote locations United States - Remote time type Full time job requisition id R-246261 Career Category Regulatory Job Description R-246261 Senior Associate - Regulatory Affairs What you will do Let’s do this. Let’s change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. - To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements. - To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions - To assist the Global Regulatory Lead to manage GRT interactions Key responsibilities include: - Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings) - Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead - Create and maintain product regulatory information and history documents through Amgen systems - Appropriately archive regulatory documents and agency communications - Collaborate with CRO’s / partners to support site initiation - Complete regulatory forms to support agency communications - Participate in GRT to support execution of regulatory strategy - Coordinate QC of regulatory documentation (e.g. briefing materials) - Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) - Assist in template development and maintenance - Respond to specific requests from and communicate relevant issues to GRT - Actively support regulatory compliance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. Basic Qualifications: Master’s degree Or Bachelor’s degree and 2 years of Regulatory Affairs experience Or Associate’s degree and 6 years of Regulatory Affairs experience Or High school diploma / GED and 8 years of Regulatory Affairs experience Preferred Qualifications: - Strong communication skills - both oral and written - Ability to understand and communicate scientific/clinical information - Ability to collaborate with team members to tackle problems and develop a course of action - Cultural awareness and sensitivity to achieve global results - Planning and organizing abilities - Able to prioritize and balance multiple activities - Ability to deal with ambiguity - Ability to influence others What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: - A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts - A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan - Stock-based long-term incentives - Award-winning time-off plans - Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Salary Range 83,974.90USD -113,613.10 USD

Role Description All staff are employed through the Research Foundation. This role will be in service to the Research Foundation. Reporting to the Chief Financial and Administrative Officer of the Research Foundation, the inaugural Senior Director of Compliance and Risk Management (CRM) is responsible for developing, implementing, and overseeing a comprehensive compliance and risk management program for the Research Foundation. The Senior Director of CRM provides strategic leadership in establishing and maintaining a comprehensive compliance framework as a fiscal sponsor providing services to a program receiving approximately $100 million in funding, of which approximately 60% is federal funds. This position ensures that all operations—particularly those related to clinical research, sponsored projects, subawards, data management, and financial stewardship—adhere to applicable laws, regulations, sponsor requirements, and institutional policies. The Senior Director of CRM serves as the organization’s principal compliance director and works closely with General Counsel, Chief Executive Officer, Chief Strategy Officer, Chief Financial and Administrative Officer, Chief Research Administration Officer, and Chief Research Information Officer to promote a culture of ethics, integrity, accountability, transparency, and regulatory excellence. The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required. Employee must reside within the United States. Full salary range for this position: $144,278 to $225,289 per year. The typical hiring range for this position is from $144,278 (minimum) to $184,784 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as, budget availability. Qualifications - Ten (10) years of progressively responsible experience in research compliance, risk management, or regulatory affairs, with at least 5 years in a management role. - Master’s degree in law, compliance, public administration, public health, business administration, or related field, or substitute with bachelor’s degree plus two additional years of related experience. - Extensive experience in an academic, nonprofit 501(c)(3), fiscal sponsor or research organization subject to substantial federal awards (e.g., NIH, DoD, NSF) and adherence to IRS regulations. - Substantial experience developing and implementing enterprise-wide compliance programs and board-level reporting according to enterprise risk management frameworks (COSO ERM) and OIG Compliance Program Guidance. - Demonstrated understanding of Uniform Guidance (2 CFR 200) and NIH Grants Policy Statement. - Deep knowledge of federal research compliance, risk management, and audit principles, including experience managing investigations and responding to audits and regulatory inquiries. - Knowledge of HIPAA, data security privacy regulations and frameworks. - Strong analytical and problem-solving skills with a strategic and detail-oriented approach. - Excellent communication and interpersonal skills, including the ability to convey complex regulatory requirements clearly to diverse audiences. - Proven ability to foster a culture of compliance and ethical accountability. - Commitment to continuous improvement and operational excellence. - Collaboration and respect across interdisciplinary teams. - Successful history of collaborating with executive leadership and general counsel. - Demonstrate exceptional integrity and transparency in all research and administrative practices. Requirements - Experience with clinical research regulatory frameworks and clinical trial compliance requirements, particularly in a cooperative group clinical trial network. - International regulatory experience. - Professional certifications (e.g., CHC, CHRC, CRA, or CCRP). - Juris Doctor degree. Benefits - Comprehensive benefit options include medical, dental, vision, 401(k), accrued Paid Time Off (PTO), Employee Assistance Program (EAP), Flexible Spending Account (FSA), cell phone and internet stipends, wellness stipend, paid holidays, and more. - Employees who work 20 hours or more per week are eligible for these benefit options.

• Design, implementation and continuous improvement of the AML/CFT compliance program for El Salvador in alignment with the global standards. • Lead and implement process improvement initiatives across operational workflows and control frameworks throughout LATAM jurisdictions. • Serve as the primary point of contact between the global compliance operations team and the local/regional team, ensuring alignment on policies, procedures, escalation protocols, and regulatory standards. • Develop scalable solutions for operational efficiency, accounting for both current regulatory requirements and anticipated changes. • Drive cross-functional collaboration to address regulatory challenges, working with Legal, Finance, Risk, and Product teams as needed. • Contribute to knowledge-sharing across compliance functions and support training efforts for the regional team. • Review and resolve escalated Transaction Monitoring cases referred by the operational team: apply senior risk-based judgment to complex or ambiguous alerts, make final suspicious activity determinations, and ensure all case documentation meets the evidentiary standard required for regulatory defensibility. • Own the preparation and timely submission of all mandatory periodic regulatory reports before local authorities.

• Design, implement, and continuously enhance IA’s global compliance program, ensuring alignment with applicable U.S., Canadian, and international regulatory requirements, with particular focus on operationalizing requirements for controlled data, technology transfers, licensing, reporting, and cross-border collaboration • Establish a cohesive compliance framework covering policies, procedures, governance, training, monitoring, and escalation • Serve as the primary compliance leader for IA, providing clear direction, prioritization, and risk based decision making • Lead IA’s compliance approach for highly regulated customer and technology environments, including U.S. export controls and nuclear regulatory regimes • Oversee compliance with applicable export control laws and regulations, including ITAR, EAR, CGP, and nuclear related requirements, across global operations • Provide practical, business oriented guidance on controlled data, technology transfers, cross border activities, and supplier engagement • Embed compliance requirements into engineering, manufacturing, IT, supply chain, and program execution, ensuring compliance is effectively and cohesively operationalized • Partner with IT to define and maintain technical and physical controls for sensitive or controlled data • Collaborate with the Corporate Compliance Centre of Excellence to ensure alignment with ATS Corporation’s global compliance frameworks, standards, and enterprise programs • Develop and maintain IA specific compliance policies, standards, and procedures consistent with corporate requirements • Conduct risk assessments, internal reviews, and compliance testing; identify gaps and lead remediation efforts • Establish metrics and reporting to provide senior leadership with clear visibility into compliance risk, trends, and program effectiveness • Design and deliver targeted compliance training for leadership, engineering, operations, supply chain, and support teams • Promote a strong compliance culture grounded in accountability, transparency, and practical problem solving • Act as a trusted advisor to business leaders on navigating complex regulatory requirements