Senior Associate Regulatory Affairs (Based in Johannesburg)

Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Local Regulatory Representative (LRR), Sr Associate WHAT YOU WILL DO Group Purpose Local Regulatory Affairs provides South Africa regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen portfolio in South Africa & Sub Sahara Africa Job Summary The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support an LRR or lead the planning and execution of regulatory strategies for a program(s) under the supervision of an experienced Local Regulatory Lead. In addition, the LRR South Africa serves as the regional regulatory intelligence focal point for Sub-Saharan Africa (SSA), supporting proactive monitoring, assessment, communication, and governance of regulatory developments across SSA markets to enable strategic planning, market expansion, and launch readiness. The role partners with Global Regulatory Affairs, Regulatory Policy, International Regulatory Leads (IRLs), distributors, and local stakeholders to identify emerging regulatory trends, assess business impact and regulatory risk, and support regulatory feasibility assessments for new market entry opportunities across SSA (Sub Sahara Africa) . Assist in aligning local regulatory requirements with Amgen’s corporate standards. Provide national/regional (as applicable) input to and execute regulatory strategies. Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements. Provide guidance on local mechanisms to optimize product development and regulatory approvals Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures. Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments) Act as the point of contact with regulatory agencies. Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc. Key Activities Strategic and Execution Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team. With close supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable. Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements. Creates, reviews, and approves source text for country labeling, and owns the country artwork based on source text. Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate). Reviews and approves the promotional and non-promotional materials. Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen. Monitors the external regulatory environment to help inform/advise in the regulatory decision making. Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments). Participates in the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed. Advises Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and