Manager, Regulatory Policy and Intelligence / 08-5415

Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind.We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future.Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy.For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City.sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

The RPI Manager collects, summarizes and disseminates regulatory information (e.g., regulations, guidance, regulatory trends) locally and globally within the Company. The RPI Manager is responsible for contributing summaries and regulatory postings to RPI Newsline (regulatory information database), sending targeted communications, coordinating the comment process and responding to ad hoc requests from the RA department.Provides updates and training on new regulations and guidance to RA and other departments in the Company.Collects, summarizes and disseminates the most recent information regarding new and revised regulations and guidance, as well as regulatory trends, locally and globally within sanofi pasteur, to keep the Company informed. This can be accomplished by sending targeted e-mails or posting documents with summaries onto RPI Newsline (regulatory information database).Analyzes and assesses the impact of new and revised regulation and guidance on sanofi pasteur business via detailed summaries and impact statements. This can be done proactively or upon request from constituents in the Company.Coordinates the comment process with other functional areas (locally and globally) and compiles/develops the comments for review by the RPI Director and submission to FDA on draft guidance and similar documents. Comments can usually be submitted to FDA dockets electronically, working with RPI Coordinator.Provides support to RA franchises to aid them in developing regulatory strategy. This is most often done upon request.Participates with RPI group in periodic assessments to evaluate performance and recommend enhancements to RPI Newsline. Helps represent sanofi pasteur interests on external industry or technical working groups as appropriate. We are an equal opportunity employer M/F/D/V

Qualifications:

BA/BS in Biology, Life Science, or related field of study; and at least 3 years prior experience in the biologics industry, preferably vaccines. Excellent communication skills.