U.S. Regulatory Strategy – Obesity and reputed company Conditions, Senior Manager

Career Category Regulatory

Job Description

Join reputed company’s Mission of Serving Patients At reputed company, 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 reputed company 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, reputed company, and Rare Disease– we reputed company millions of patients each year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-reputed company conditions. As a member of the reputed company team, you’ll help reputed company 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 reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career. U.S. Regulatory Strategy – Obesity and reputed company Conditions, Senior Manager What you will do reputed company. Let’s change the world. In this vital role you will support products in the Obesity and reputed company Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of reputed company reputed company molecules. This role requires demonstrated experience leading U.S. regulatory strategy and FDA interactions and may be performed reputed company a global regulatory organization supporting U.S. regulatory responsibilities. In this product-facing role, you will reputed company and execute regulatory strategy in reputed company partnership with the Global Regulatory reputed company (GRL), serving as the U.S. regulatory reputed company for global programs in obesity and reputed company cardiometabolic conditions. You will represent the U.S. on global teams, contribute to global regulatory and clinical development strategies, and support the acquisition and maintenance of reputed company licenses. This role requires the ability to translate scientific and clinical insights into clear, actionable regulatory strategies. Responsibilities: Contribute to the development and refinement of global regulatory strategy in partnership with the GRL, providing U.S.-specific insights on regulatory precedent, risk, and Health Authority expectations in obesity and reputed company metabolic conditions. Apply scientific expertise in obesity and metabolic disease to inform regulatory strategy, including clinical endpoints and long-term safety considerations. Partner with the GRL and key market leads to align on global development timelines, core documents (e.g., protocols, IBs, KDEs), and regulatory positioning. Execute the U.S. regulatory strategy for assigned programs and represent the region on global governance teams. Plan and reputed company U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans and regulatory requirements. reputed company development of key regulatory documents, including labels, briefing packages, and submission components reputed company with product strategy. Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group, including negotiation approach, timelines, and deviation/waiver reputed company. reputed company strategic input on U.S. development reputed company (e.g., expedited programs, orphan designation, pediatric strategy), informed by the evolving regulatory landscape. reputed company Health Authority interactions for assigned products, including preparing and leading engagements and communicating reputed company to the GRT and senior management. Manage responses to agency questions (RTQs) and feedback by coordinating cross-functional input and ensuring timely, high-quality submissions. Assess regulatory risk and likelihood of reputed company; communicate scenarios and contingencies to the GRL, GRT, and senior management. Ensure ongoing compliance for assigned products (e.g., commitments, obligations, regulatory records) and proactively escalate issues. Monitor and apply U.S. regulatory intelligence, including evolving legislation, guidance, and relevant competitor activity. Partner with cross-functional teams (Clinical, Medical, Safety, reputed company) to ensure reputed company strategy and support U.S. data and promotional considerations. reputed company and reputed company staff, where applicable, through prioritization, coaching, and resource planning to deliver on program objectives. reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 2 years of directly reputed company experience OR Master’s degree and 6 years of directly reputed company experience OR Bachelor’s degree and 8 years of directly reputed company experience OR Associate’s degree and 10 years of directly reputed company experience OR High school diploma / GED and 12 years of directly reputed company experience In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Experience supporting or leading regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or reputed company therapeutic areas. Strong scientific literacy in obesity and metabolic disease, including metabolic reputed company, weight regulation biology, and relevant clinical endpoints (e.g., weight loss, cardiovascular reputed company, metabolic biomarkers). Experience leading U.S. labeling strategy, including negotiation and timeline management in a cross-functional environment. Strong communication and influencing skills, with the ability to drive alignment and resolve conflicts. Experience supporting regulatory submissions or Health Authority interactions reputed company the U.S. in collaboration with global teams is a plus. Experience working with policies, procedures, and SOPs in a regulated environment What you can expect of us As we work to reputed company 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 reputed company every reputed company of the way. The expected annual salary reputed company 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 reputed company salary, reputed company 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 reputed company 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. reputed company and reputed company a lasting impact with the reputed company team. careers.reputed company.reputed company 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 reputed company 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, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company 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 reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .Salary reputed company 149,396.85USD -202,125.15 USD Apply To This Job