• Serve as a microbiology and contamination control subject matter expert for Quality Compliance, QC laboratories, manufacturing, and site teams. • Support the contamination control program, including site engagement, network participation, metrics review, risk identification, and escalation of significant concerns. • Contribute to the development, revision, and implementation of global microbiology and contamination control standards, procedures, technical guidance, and quality intelligence documents. • Support periodic contamination control reviews, trend evaluations, and state-of-control assessments for in-scope sites, processes, and products. • Provide technical input for environmental monitoring, bioburden control, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls. • Partner with site Quality, Manufacturing, Engineering, and QC laboratories to promote consistent application of contamination control expectations. • Provide technical review and recommendations for microbiology investigations, deviations, CAPAs, risk assessments, change controls, audit observations, and inspection commitments. • Support evaluation and implementation of new or improved microbiology methods, technologies, laboratory practices, and contamination control tools. • Contribute to Microbiology Center of Excellence activities, technical forums, communities of practice, and network alignment discussions. • Support regulatory inspections, internal audits, health authority commitments, and inspection-readiness activities related to microbiology, contamination control, QC laboratories, and manufacturing controls. • Provide technical input to audit responses, regulatory inspection responses, CAPA plans, and effectiveness checks. • Review regulatory filings, responses, or technical documents for microbiology-related content, as assigned. • Monitor relevant regulatory, compendial, and industry developments and help translate them into practical expectations for sites and functions. • Lead or support cross-functional projects related to microbiology, contamination control, laboratory practices, inspection readiness, or quality improvement.

• Serve as a aseptic processing and contamination control subject matter expert for Quality Compliance, Manufacturing, and site teams. • Support the contamination control program, including site engagement, network participation, metrics review, risk identification, and escalation of significant concerns. • Contribute to the development, revision, and implementation of global aseptic processing and contamination control standards, procedures, technical guidance, and quality intelligence documents. • Support periodic contamination control reviews, trend evaluations, and state-of-control assessments for in-scope sites, processes, and products. • Provide technical input for environmental monitoring, bioburden control, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls. • Partner with site Quality, Manufacturing, Engineering, and QC laboratories to promote consistent application of contamination control expectations. • Provide technical review and recommendations for microbiology investigations, deviations, CAPAs, risk assessments, change controls, audit observations, and inspection commitments. • Support evaluation and implementation of new or improved technologies, practices, and contamination control tools. • Contribute to Global Aseptic Council activities, technical forums, communities of practice, and network alignment discussions. • Support regulatory inspections, internal audits, health authority commitments, and inspection-readiness activities related to microbiology, contamination control, QC laboratories, and manufacturing controls. • Provide technical input to audit responses, regulatory inspection responses, CAPA plans, and effectiveness checks. • Review regulatory filings, responses, or technical documents for aseptic processing -related content, as assigned. • Monitor relevant regulatory, compendial, and industry developments and help translate them into practical expectations for sites and functions. • Lead or support cross-functional projects related to aseptic processes, contamination control, laboratory practices, inspection readiness, or quality improvement.

• Reads and comprehends retirement plan provisions from plan documents to ensure accuracy and compliance with regulations • Supports DOL, IRS, and Large plan audits • Is responsible for plan administration, compliance and testing for identified blocks of business • Prepares annual valuation and compliance reports for Clients • Responsible for protecting, securing, and proper handling of all confidential data

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