• Build and maintain a positive and productive liaison with internal and external contacts • Use various internet document transfer sites to download client files and upload files ready to be sent back to clients • Use, manage, and maintain submission files within company systems as per company standard • Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, and Power Point • Create eCTD submissions using an eCTD submissions builder, validation software, and an electronic submissions viewer • Create NeeS submissions, as needed, and coordinate any necessary shipments • Quality check and provide accurate feedback on all submission types • Independently troubleshoot and fix issues on a document and submission level • Send eCTD submissions via the ESG NextGen Portal • Save submissions to external media and arrange for parcel delivery (if required) • Enter time into the company time recording system on a daily basis • Attend and contribute to weekly department meetings, helping bring innovative solutions to promote growth and new business • Assist in writing marketing materials, if required • Maintain professional regulatory and documentary knowledge to provide effective consulting advice • Coordinate work ensuring all submissions and communications are covered fully, accurately, and completely to department standards • Effectively manage and prioritize both billable and unbillable work • Effectively delegate work to ensure all submissions are available for external QC in a timely manner • Assist with the creation and review of process documentation/SOPs • Involved with training of other department members, as needed • Publish, validate, and submit XML Product Monographs and SPLs if assigned • Create ASCII datasets as needed if assigned • Troubleshoot and mitigate IT issues within the department and provide systems-related support if assigned • Lead and complete PRCI projects if assigned • Complete additional department services as required

• Develop and lead global regulatory strategies for Phase 2 and Phase 3 clinical development programs • Provide regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways • Evaluate regulatory risks and opportunities and develop mitigation strategies to support program objectives • Lead regulatory planning for major milestones, including End-of-Phase 2 meetings, Scientific Advice procedures, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications • Serve as the regulatory representative on cross-functional program teams and governance committees • Lead preparation, coordination, and execution of global regulatory agency meetings and interactions • Develop briefing documents, regulatory questions, meeting strategies, and response packages • Represent the company during regulatory agency meetings and negotiations • Ensure alignment of regulatory strategy across regions while addressing local market requirements • Oversee the preparation and submission of global regulatory documents, including: INDs and IND amendments, Clinical Trial Applications (CTAs), Annual reports and Development Safety Update Reports (DSURs), Pediatric plans and orphan drug submissions, NDA, BLA, MAA, and other marketing applications • Review and approve key submission documents to ensure regulatory compliance, scientific integrity, and strategic consistency • Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory considerations into development plans • Provide regulatory leadership for label development and commercialization planning • Support due diligence activities, business development initiatives, and portfolio evaluations as needed • Mentor and develop regulatory staff and contribute to building organizational regulatory capabilities • Monitor evolving global regulatory requirements, guidance documents, and industry trends • Assess potential impact of regulatory changes on development programs and advise leadership accordingly • Ensure compliance with applicable regulatory regulations, guidelines, and company procedures

• Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan • Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling • Provides regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent • Leads development, review and approval of the target product label (TPL) • Obtains input from the GRT members (e.g. RRLs, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance • Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes) • Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents) • Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions • Monitors and assess impact of relevant global regulations, guidances, and current regulatory environment • Ensures guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy • Consistently communicates well defined, successful regulatory strategies throughout the organization such that expectation is understood • Produces strategies that provide innovative alternatives which communicate the associated risks • Communicates Amgen’s position consistently cross-functionally and across all documents • Develops the ability to articulate and educate the likelihood of regulatory success based on proposed strategies • Develops ability to accurately predict expectations and outcomes by regulatory agencies • Directs global regulatory agency interaction strategies, in collaboration with regional colleagues • Ensures effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams) • Ensures consistent communication of product information to Health Authorities • Attends key regulatory agency meetings which could impact the global product strategy • Leads GRT to develop and execute team goals • Provides coaching and mentoring to GRT members • Integrates regional regulatory representative input into GRT and regulatory plans • Communicates and ensures alignment of global functional and cross-functional goals and objectives • Represents Global Regulatory Affairs on key commercialization teams (e.g, PT, EGT, GST) • Represents Amgen GRA on external partnership teams at the PT level • Provides education and training on regulatory strategies and compliance issues to other PT functions • Ensures regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments) • Advocates for Amgen/GRAAS by building strong relationships with key external stakeholders including senior regulatory agencies, trade associations, and influential professional bodies • Works externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area • Develop regulatory due diligence assessment of licensing/acquisition opportunities as assigned by management.

• Provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment • Ensure truthful and non-misleading communication to health care community, patients, and the public • Formulate and communicate the regulatory promotional position for approved and/or pipeline products • Promotional review committee experience in evaluating proposed pieces and supporting evidence • Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen • Update the Promotions group on new learning’s and key takeaways from courses, congresses, and tradeshows • Mentor Senior Associate and Manager level reviewers • Assess promotional programs against Regulatory requirements • Identify changes required to meet Promotional Regulation