Global Submission Lead

Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the role As Global Submission Lead within our R&D team, you will be responsible for the planning, coordination, and tracking of regulatory Priority portfolio and Integration submission activities for assigned programs at Sanofi. This position ensures optimal expertise on all dossier formats, standards, navigation, and life cycle management globally. Main responsibilities Plan and deliver worldwide regulatory submissions required to support the development and registration of new global products. Represent GRO Submissions Management in the development of global submission filing plans and actively participate in Global Regulatory Product Teams as part of the GRA BluePrint model. Act as a Regulatory Operations Team expert providing subject‑matter advice on ICH, eCTD, and electronic submission requirements, as well as other relevant regulatory guidelines. Lead the creation and maintenance of submission plans based on a thorough understanding of publishing tools and processes. Lead project teams to ensure control of submission component receipt and workflow completion, identifying and resolving issues early to avoid filing delays. Ensure delivery of high‑quality, timely submissions to global regulatory health authorities aligned with Sanofi and Health Authority standards. Remain fluent and current on global regulatory guidelines and approval processes, procedures, and submission templates to ensure compliance with internal and external requirements. Operate as a subject‑matter expert in dossier types and processes with responsibility for training and mentoring GRO peers. Provide oversight and manage vendors to support regulatory submissions goals. Act as a key point of contact for leadership to establish trusting partnerships with external co‑developer pharmaceutical companies for e‑Submission strategies. Coordinate with Regulatory Operations external equivalents to develop milestones and timelines and ensure success in achieving goals and business continuity. Drive operational effectiveness, supporting the implementation of standards and process efficiencies for submission publishing, and assist in the writing and review of process documentation. Oversee continuous improvement and integrity of GRO systems and procedures. Represent GRO in GRA special initiatives. Qualifications Bachelor’s degree (or equivalent) in regulatory affairs, life sciences, or related field. 5+ years of experience in the pharmaceutical industry related to regulatory operations or equivalent/relevant experience. High degree of knowledge of the dossier assembly/production process, structural organization, standards, and requirements of regulatory dossiers. Understanding of FDA, EU regulations, ICH guidelines, and other global regulatory requirements and submission processes. Working knowledge of drug laws, regulations, and guidelines. Proficiency in Microsoft Windows environment and Windows‑based desktop productivity applications (MS Office, Adobe Acrobat). Knowledge of Veeva Vault is a plus. Self‑starter with strong leadership skills, strong attention to detail, and excellent verbal and written communication skills. Ability to work across cultures and lead projects and timelines in a matrix team environment. Past experience in regulatory submission planning is preferred. Additional requirements This position may require some domestic and international travel. It requires successful collaboration on cross‑functional teams and interactions with external partners. Benefits Sanofi offers a comprehensive rewards package that includes high‑quality healthcare coverage, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave. Employees are eligible to participate in company benefit programs and may be eligible for internal salary adjustments based on experience. Equal Opportunity Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, gender, sexual orientation, disability, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr Sanofi