At Opella, the Consumer Healthcare Division of Sanofi, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world. **Job Summary:** The Global Switch Science Lead is responsible for leading the switch development program to approval of an assigned Rx-OTC Switch asset in target market (ex-US markets). This role involves developing and executing program strategies for global programs, interacting with cross-functional teams, and collaborating with internal and key external stakeholders. The individual will manage regulatory experts as direct report. Works closely with the Global Commercial Lead. The ideal candidate is an experienced leader, who has a deep understanding of the Rx-OTC switch requirements and regulatory approval process, strong leadership skills, and a history of successful switch programs. **Key Responsibilities:** + Oversees, entire switch science program and associated work streams involved. This will include both direct reports and matrixed colleagues with the intent on delivering against the switch priorities. + Oversees budget and timeline in association with project management. Provide switch science leadership to deliver against key switch milestones and within budget. + Ensure that all documents to be submitted to regulators represent the aligned program strategy, are complete, accurate, compliant with global and/or local submission requirements and standards and are organized in a manner to facilitate regulatory review. This applies for both development and registration dossiers. Lead and actively participate in the development of strategies for Health Authority interactions. + Proactively help to drive the business by looking at ways to deliver the switch programs in a time efficient manner whilst meeting financial spend estimates. + Engage with and update management on progress against key deliverables. + Represent the science team in alliance partner meetings. + Lead external partner interactions and engagement with the cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy. + Collaborate with stakeholders from various departments, including leadership, science, regulatory, safety, real-world evidence, and behavioral science, global medical affairs, commercial and consumer insights. Strong partnering and collaboration with the R&D and SMEs within and across switch teams. + Understand Rx-OTC Switch, the healthcare environment (including social & policy trends); anticipate the self-care future and changes that will impact the CHC portfolio. Provide clear advice on future trends, competitive intelligence and emerging requirements for development programs and help to drive innovation. + Serves as a switch science educational resource to both internal and external customers. + Rx-OTC Switch Ex-US + Understands the external and regulatory environment in ex-US markets (e.g. Europe, Japan, Australia etc.) to drive switch strategy in these markets. Establishes an overall global switch strategy utilizing insights from each target market. + Collaborates with markets/regions, on developing the overall program strategy including their strategies regarding Regulatory Agency interactions for switch-related projects. **About You:** **Education:** + Minimum B.S. An advanced degree such as MS, PhD, or PharmD or equivalent preferred. **Experience:** + 15+ years of relevant experience with about 5 years switch experience with a track level in delivery. + Demonstrated success in completing key switch milestones in OTC environments. + Possesses a strong knowledge of the regulatory/medical requirements across the target markets. + Experience in global or regional roles. + Proven experience in Health Authority interactions and registration/approvals in ex-US countries + Experience in clinical and consumer studies relevant to switch products is desired. **Specialized Knowledge/Skills:** + Proven history of managing direct reports, working cross-functionally collaboratively and leading projects. + Strategic & analytical thinking; Adaptability and flexibility to constant changing business and regulatory environment. + Excellent communicator both written and verbal. Opella offers hybrid environment requiring 2 – 3 days in office and the requirements will vary dependent on business needs. **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)