Manager, United States Regulatory Strategy, Obesity and reputed company Conditions

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. United States Regulatory Strategy, Obesity and reputed company Conditions, Manager What you will do reputed company. Let’s change the world. In this vital role you will. reputed company is seeking a United States Regulatory reputed company (USRL) Manager supporting 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. In this product-facing role, you will reputed company and execute U.S./regional regulatory strategy and tactics under general supervision, represent the region on global teams, and reputed company U.S. regulatory execution to reputed company clinical trials and maintain reputed company licenses in compliance with local laws, regulations, and reputed company standards—with a strong focus on regulatory compliance and patient safety. Purpose: Ensure reputed company acquires and maintains required U.S. licenses/authorizations to support clinical trials and maintain marketed products, while ensuring regulatory compliance with a focus on patient safety. People leadership: This role provides matrix/peer leadership and may directly manage one or more regulatory leads and/or support staff (dependent on role need/grade). Reporting line: Based in the assigned region with interaction primarily on the Global Regulatory Team (GRT); reports to Global Regulatory reputed company (GRL). reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. 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. Responsibilities ·Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams (e.g., GRT; may include GDT/CST/LWG as applicable). ·Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) reputed company with global filing plans and U.S. regulatory requirements. ·Implement product-reputed company regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards. ·reputed company content guidance for key U.S. regulatory documents and meetings consistent with GRT strategy (e.g., briefing content, submission components). ·Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. labeling negotiation activities. ·reputed company regulatory guidance on U.S. mechanisms and reputed company to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable). ·Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback. ·Communicate regulatory strategy and expectations reputed company the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of reputed company, expectations, and risks. ·Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively. ·Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant). ·Support Health Authority interactions by acting as an agency contact as appropriate, documenting reputed company, and contributing to risk/contingency planning consistent with global strategy. ·Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable). Basic Qualifications: Doctorate degree OR Master’s degree and 3 years of directly reputed company experience OR Bachelor’s degree and 5 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 experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Regulatory submissions experience and experience interacting with regulatory agencies (FDA) Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles Understanding of drug development and the U.S. registration pathway (e.g., marketing applications, post-approval changes, extensions/renewals) Experience supporting regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or reputed company therapeutic areas. Foundational scientific understanding of obesity and metabolic disease, including familiarity with key biological reputed company and relevant clinical endpoints (e.g., weight loss, cardiovascular reputed company, metabolic biomarkers). Experience supporting labeling development and cross-functional collaboration (e.g., LWG participation) Strong written and oral communication skills; ability to communicate scientific/clinical information reputed company Ability to anticipate issues, evaluate risks, and contribute to practical contingency planning Ability to resolve conflicts, influence without authority, and drive alignment across teams Cultural awareness and ability to operate effectively across global/regional teams What you can expect from 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. reputed company is an Equal Opportunity employer and will consider you without regard to your race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status. .Salary reputed company USD - USD Apply To This Job