Regulatory Affairs Manager - US Regulatory Lead, Rare Disease

Regulatory Affairs Manager - US Regulatory Lead, Rare Disease What you will do Let’s do this. Let’s change the world. The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services. In this vital role you will be assigned to one or more Amgen products, and plan and execute the Regulatory strategies for that product(s) in their country(ies). Specific responsibilities include but are not limited to: Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission). Act as the point of contact with regulatory agencies. Provide guidance on local mechanisms to optimize product development and regulatory approvals. Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements. Ensure and support local regulatory product compliance (eg, agency commitments). Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures. Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Plans, labeling documents, etc. Assist the GRL by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions. Provide primary authorship to routine regulatory correspondence. 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 leader with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Regulatory Affairs experience OR Bachelor’s degree and 4 years of Regulatory Affairs experience OR Associates degree and 8 years of Regulatory Affairs experience OR High school diploma / GED and 10 years of Regulatory Affairs experience Preferred Qualifications: Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum Regulated industry, science or clinical practice experience Organizational skills - detail oriented and can deal with frequent changes in product activity What you can expect from us 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 112,744.00USD -152,536.00 USD 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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Sponsorship for this role is not guaranteed. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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 biologics manufacturing 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. For more information, visit and follow us on #J-18808-Ljbffr 2001 Horizon Therapeutics USA, Inc.