Manager RA Product II / US-06C-099

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 one 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

1. Product Regulatory Strategy: Develops the regulatory strategy for the project/product. This involves:
- Obtaining requirements for elements of project development plan that relate to RA.
- Developing the Regulatory Strategy Document (RSD) and/or
- Regulatory Impact Assessment (RIA), keeping the document updated throughout the life of the project/product, and including relevant parts of the RSD in the Project File.
- Ensuring the coordination of the RSD/RIA with the Clinical Develop-ment Plan, the Product Development Plan and the Marketing Strategy, IO, and other relevant functional areas; participates in the development and maintenance of the Core Data Sheet.

2. Regulatory Submissions: Develops and executes the submission strategy according to the RSD or the RIA. Prepares and coordinates regulatory submissions for regulatory authorities and/or third parties. Organizes the compilation, review, and approval of documents for the submissions and of the entire submission, writes documents and summaries as required, and provides editorial review for all components of regulatory applications and submissions. Ensures preparation of the components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and coordinates the final submissions to regulatory authorities and/or to third parties.

3. Organizational Reporting: Responsible for reporting on progress and specific issues pertaining to product responsibilities and providing regula-tory project reviews, as required (e.g., to CRSF, RAC, PMPT, IOMC).

4. Planning/Coordination: Responsible for the planning and coordination of regulatory activites relating to local/global projects from intiation to approval, which include detailed plan prioritization and coordination of activities among functional areas and Regulatory Operations. Developing project related regulatory objectives and target dates, providing timelines for critical regulatory activities to be incorporated into the project plan



5. Health Authority (HA) Contacts: Manages contacts with regulatory agencies or third parties. The RPM is responsible for the notification and inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed. The RPM discusses and may negotiate issues with regulatory authorities; and communicates, documents and archives information for the organization. Responsible for notification to relevant functional areas regarding regulatory authority communications. Sets up the necessary meetings with regulatory authorities and co-ordinates the preparation of the pre-reads and the presentations.

6. Health Authority (HA) Commitments & Documents: Responsible for tracking regulatory authority requests and commitments and to manage completion of those, as well as, keeping registration data updated and verified (e.g., eTRAC, Documentum folders, etc). Ensures registration data (product/project submission files, communications, etc.) are properly archived in accordance with established procedures.

7. Health Authority (HA) Inspection Preparation/Support: The RPM participates in inspection preparation and interfaces with Facilities and Compliance to provide inspection support, as requested.

8. Staff Management & Development: The RPM may provide line management support for direct reports, including staff development, coaching, and performance appraisal.

9. Regulatory Guidance: Responsible for providing regulatory advice and guidance to Project/Product Team members and other functional areas on regulatory matters. This could include:
- Providing information from regulatory requirements documents and other appropriate guidance documents.
- Providing training and education on regulatory policies, procedures and documents in collaboration with RPI

10. Communications: Responsible for communicating within and across RA product franchises and other functional areas on relevant product/project issues and developments; including the sharing of industry practices and experiences. Responsible for keeping the Regulatory Product Leader (RPL) continuously informed about project/product status and issues, this includes the expectation to raise appropriate issues for the RPL to present to steering committes, which may include the preparation of briefing documents, postion papers, and proposals.

11. Personal Development: Responsible for staying up-to-date on regulatory guidances and technical/scientific developments pertaining to the product franchise. Assesses impact on areas of product responsibilities, communicates to organization and, in collaboration with RPI, comments on draft regulations and assesses future areas for influencing the regulatory environment.

12. RA Process Development Support: Provides product-related input and resources towards the development and implementation of new RA systems, procedures, and/or tools.

We are an equal opportunity employer M/F/D/V

Qualifications:

Bachelor's degree in scientific discipline required. Graduate level scientific degree/education is desirable. 2+ years experience in regulatory affairs. Detailed knowledge of drug development and manufacturing and supply process. Detailed working knowledge of worldwide regulatory requirements. Project team experience preferred.