Regulatory Affairs Manager (US) - United States
Responsibilities for the Regulatory Affairs Manager include:
Ensure that Amgen acquires and maintains all the licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
Ensure regulatory compliance, with a focus on patient safety.
Provide management and leadership by supervising one or more other regional regulatory leads and/or support staff.
Execute the approved regional strategy for assigned programs.
Advise the Global Regulatory Team (GRT) on regional considerations in developing strategy.
Ensure the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provide content guidance for regional regulatory documents and meetings in accordance with GRT strategy.
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan).
Manage the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
Support regional label negotiation activities.
Under general supervision participate in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
Obtain and maintain Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
Communicate regulatory strategies within team (e.g. GRT, local affiliates).
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments).
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 obtain relevant histories, precedence and other information relevant to regional product advancement.
Master's Degree & 3 years of Regulatory experience
Bachelor's Degree & 5 years of Regulatory experience
Associate's degree & 10 years of Regulatory experience
High school diploma/GED & 12 years of Regulatory experience
Regulatory submissions experience
Experience interacting with regulatory agencies
Clinical Development experience
Cross-functional experience Knowledge and Skills
Working with policies, procedures and SOP’s
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 Scientific / Technical Excellence
Communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
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
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.