Regulatory Affairs Senior Manager – Regional Regulatory Lead

Career Category Regulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Regulatory Affairs Senior Manager – Regional Regulatory Lead What you will do Let’s do this. Let’s change the world. In this vital role you will achieve the desired labeling by developing and executing US regulatory strategies within the obesity and metabolic disease therapeutic area. 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 - Under supervision evaluate and communicate impact of relevant US regulations, guidance’s, current regulatory environment, and competitor labeling - With general supervision, 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 - Under general supervision, 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 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 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 What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. 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. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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. #obesity . Salary Range 142,579.00USD -192,901.00 USD