Manager Regulatory Affairs / 08-4944

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 Regulatory Product Manager (RPM) has the local and/or global responsibility of or several products within a product franchise. The RPM serves on local and/or global projects and is responsible for managing all the regulatory aspects of the product(s) throughout the product life cycles. The position may manage and develop staff in Regulatory Affairs.Key Accountabilities for this position include the following:Development of Regulatory Strategy Document and Regulatory Impact Analysis;Coordination and preparation of Regulatory Submissions;Organizational Reporting on Project and Product issues;Regulatory Activity Planning and Coordination;Maintenance and Facilitation of Health Authority Contacts;Tracking and Management of HA Commitments and Documents;Providing Regulatory Guidance and Advice;Regulatory Process Development Support.Sanofi pasteur is an equal opportunity employer M/F/D/V.

Qualifications:

B.S. with 1 - 2 years regulatory affairs experience; advanced degree strongly preferredExperience with preparing FDA submissions, including IND, NDA, or BLA submissionsKnowledge of cGMPs, ICHs, CTDs, and biologics drug product regulationsExcellent communication skills required