
Regulatory Submission lead
莫里斯敦, 新泽西州剑桥, 麻薩諸塞州 Permanent 发布于 Sep. 05, 2025 申请截止于 Dec. 19, 2025 Salary Range USD 122,250.00 - 176,583.33
Job Title: Regulatory Submission lead
Location: Morristown, NJ Cambridge, MA
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Submission Lead is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to drive Global Simultaneous Submission (GSS) filing execution plans for Sanofi’s priority portfolio. The Submission Lead is also the GRO Submissions Management focal point for Mergers & Acquisitions integration and Joint Venture project teams and is directly involved in relationship building, ensuring achievement of business goals and protecting business continuity.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Submission Management Activities:
Act as key partner to the GRL and project teams by applying global submissions management expertise in the design, planning and delivery of the GSS filing plans for Sanofi R&D’s priority growth assets
Represent GRO on the Global Regulatory Teams for Sanofi GBU priority assets, per the GRA BluePrint model
Act as Project Leader for the GRO Submissions Management Task Force (SMTF), managing global colleagues in a matrix environment to ensure alignment, visibility and timely delivery across all platforms for the GSS filings
Accountable for the delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority standards. Provides analysis, tracking, communication and issue escalation/resolution on overall operational activities based on input from technical experts (Submission Managers, Submission Associates and/or Publishers)
Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted
Act 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
Remain fluent and current on global regulatory guidelines and approval processes, procedures and submission templates to ensure compliance with internal/external requirements
Direct and mentor trainees and interns
Partner and support Submissions Management Leadership in the management of GRO activity for Sanofi GRA’s priority submissions portfolio, the submission forecast and ensuring proper staffing for upcoming submissions
Create and manage resourcing and budget plans, as needed
Submission Partnerships and Integrations:
Act as a key contact in managing complex joint ventures and designing e-submission strategies between the 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
Act as focal point on M&A integration project teams to build relationships, develop timelines and achieve milestones to protect business goals and business continuity. Partner closely with GRO colleagues on integration plans
Provide oversight and manage vendors to support Regulatory submissions goals and integration timelines
Drive Operational Effectiveness:
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
Requirements:
Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience
6+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience
High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers
Project management experience is preferred
Working knowledge of drug laws, regulations and guidelines is essential
Ability to work across cultures
Why Choose us:
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s 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.
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, 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.
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进步需要我们每个人的参与——不论其背景、地域、或职业,我们都有一个共同的愿望:创造奇迹。你也可以成为其中的一员。我们不断追求变革,拥抱新思想,探索我们所能提供的一切机会。让我们一起追求进步。共同发现非凡。
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观看 “在赛诺菲的一天” ,并在官网 (sanofi.com) 上查看赛诺菲的多元化、公平与包容倡议!

在美国的职位
加入我们的美国团队。我们将为您提供专家指导和培训平台,从而帮助我们营造良好的企业文化。我们鼓励您以饱满的热情和充沛的精力投入到工作中,然后发挥自身能力推进药物和疫苗的研发,同时将研发到临床治疗的时间减半。
体验可能性
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