Regulatory Affairs Senior Manager – Regional Regulatory Lead

Responsibilities

• Execute the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US
• Provide content for and coordinate US regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions)
• Develop US regulatory strategies
• Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line management
• Develop regulatory risks and predictions of interactions with regulatory agencies
• Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
• Provide regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan)
• Exchange regulatory information with GRT and cross-functional colleagues on an ongoing basis and provide advice on regional considerations
• Communicate and ensure alignment of regional management before GRT strategy decisions
• Partner with regional management and peers to ensure consistency in procedures and agency interactions
• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
• Perform regulatory research to acquire relevant histories, precedence and other information relevant to product advancement in the US
• Evaluate and communicate impact of relevant US regulations, guidance, current regulatory environment, and competitor labeling
• Serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment
• Document and communicate details and outcomes of FDA interactions to GRT and relevant Sr. management
• Participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment
• Manage the development of the US product label by collaborating with the Labeling Working Group in the context of available and expected scientific data, regulatory guidance and precedent, support label negotiations
• Advise and support promotion group regarding applicability of data for product communication in the US
• Keep regulatory intelligence tool(s) current

Basic Qualifications

• Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development
• Or Master's degree and 4 years of experience in regulatory or pharmaceutical drug development
• Or Bachelor's degree and 6 years of experience in regulatory or pharmaceutical drug development
• Or Associate's degree and 10 years of experience in regulatory or pharmaceutical drug development
• Or High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug development

Preferred Qualifications

• Experience in cardiometabolic therapeutic area highly preferred
• Regulatory submissions experience (eg, INDs or CTAs)
• Experience interacting with regulatory agencies
• Knowledge of regulatory principles
• Working with policies, procedures, and SOPs
• Knowledge of national legislation and regulations relating to medicinal products
• Awareness of the registration procedures in region for MA, post approval changes, extensions, and renewals
• Knowledge of drug development
• Teamwork
• Communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Understanding of regulatory activities and their touch points
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness and sensitivity to achieve results across both regional country and international borders