Global Submission Lead

Location: Morristown, NJ / Cambridge, MA. Job title: Global Submission Lead About The Job 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. The Priority Portfolio and Integration team is committed to fostering a team culture of ownership and accountability, including continuous evaluation to drive operational effectiveness for regulatory submissions. This culture extends to our engagement and collaboration within GRA and with cross-functional stakeholders and external partners, ensuring seamless execution and delivery of high-quality regulatory submissions that support Sanofi's mission to bring innovative medicines to patients worldwide. Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions. Main Responsibilities Submission Management Activities Responsible for leading the planning and delivery of 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 participating in Global Regulatory Product Teams as part of the GRA BluePrint model. Acts as Regulatory Operations Team expert providing subject matter advice on ICH, eCTD, and electronic submission requirements, as well as other pertinent regulatory guidelines relating to the format of regulatory submissions. Leads creation and maintenance of submission plan based on a thorough understanding of publishing tools and processes. Leads project teams to ensure the control of submission component receipt and workflow completion Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted Ensure delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both 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/external requirements. Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring GRO peers Provide oversight and manage vendors to support Regulatory submissions goals. Submission Partnerships Act as a key point of contact for leadership in establishing trusting partnerships with external co-developer pharmaceutical companies for implementation of e-Submission strategies between two companies. Ensure that the team follows and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application. Coordinate with Regulatory Operations external equivalent to develop milestones and timelines and ensures success in obtaining goals and ensuring business continuity. Drive Operational Effectiveness Support in the implementation of standards and process efficiencies for submission publishing and support effective change-management communications. May assist in the writing and review of process documentation, including SOPs and Policy documents. Oversee the continuous improvement, development and integrity of GRO systems and procedures. Lead and/or represent GRO in GRA special initiatives. About You Education & Experience: Bachelors degree, or equivalent, in regulatory affairs, life sciences, or related areas of study. 5+ years of experience in the pharmaceutical industry, related to regulatory operations or equivalent/relevant experience. High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers, is required. Understanding of Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines, alongside strong understanding of global regulatory requirements and submission processes is required. Working knowledge of drug laws, regulations and guidelines. Technical & Soft Skills Ability to work across cultures is required. Past experience in regulatory submission planning is preferred. Applicable knowledge of the drug development process is a plus. Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required. Knowledge of Veeva Vault is a plus. Self-starter with strong leadership skills, who motivates, has tact, diplomacy, and a flexible and positive approach. Ability to lead projects and timelines in a matrix team environment. Strong attention to detail and accuracy. Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization. Additional Requirements Of The Job This position may require some domestic and international travel. This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data. This position requires successful collaboration on cross-functional teams and interactions with external partners. Why choose us Bring the miracles of science to life alongside a supportive, futurefocused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. Help improve the lives of millions of people globally by making drugdevelopment quicker and more effective. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmitive 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, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. #J-18808-Ljbffr BioSpace