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Manager, Regulatory Affairs CMC

Swiftwater, Pennsylvania

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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Responsibilities

Sanofi Pasteur, the Vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases.

The company's heritage, to create vaccines that protect life, dates back more than a century.  Every day, the company invests more than one million Euros in research and development.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.

The Manager, Regulatory Affairs CMC will have responsibility to lead one or more major projects in the Bacterial CMC Group (encompassing Innovation/Nosocomial and Pneumo/Meninge) for products under various phase of development (Pre-IND through Phase III and subsequent BLA filings).

  • The position will serve as the RA CMC point of contact on local and global regulatory teams focusing on topics, including but not limited to, clinical development and market expansion; Lead CMC working groups as required
  • Author, review, approve and contribute to submission-grade documents for project and regulatory files (INDs, CTAs, BLAs, CTDs, etc.) for US, Canada, and International filings; Contribute to GRPS where required.
  • Perform change control assessments and prepare regulatory impact assessments and regulatory strategies
  • Manage and/or participate in Health Authority interactions with agencies such as USFDA-CBER or CDER, EMA, Health Canada-BGTD, and other international agencies. 
  • Responsible for the oversight of Regulatory Affairs CMC contractor staffing, including budgeting, recruiting/hiring, day to day activity management, etc.
  • Serve as the Regulatory Point of Contact for Industrial Affairs and Manufacturing Technologies for various projects/products; provide guidance/feedback/input on such topics as process validation to ensure alignment with current global regulatory guidelines and Health Authority expectations
  • Review and approval of quality documents such as stability reports/protocols, validation project plans, SOPs and SWIs, etc. where applicable
  • Represent Regulatory Affairs CMC Swiftwater on internal global regulatory projects/teams for topics related to ways of working and harmonization of regulatory processes and procedures
  • The Manager, Regulatory Affairs, is mandated to take the initiative to organize and lead contacts with regulatory agencies or third parties where CMC related issues/topics are concerned and 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.
  • Main focus/challenge will be on the development and execution of the regulatory strategy, as well as authoring, review and approval for the CMC components of regulatory applications and submissions and the management and coordination of various regulatory activities, as they pertain to CMC, through the life of the project/product.

Qualifications:

Basic Qualifications:

  • BA/BS in Science is required (major in Biology or Life Science preferred)
  • 3 or more years of prior Regulatory Affairs experience required
  • Experience working on Project teams.
  • Requires in depth knowledge and understanding of the CMC topics, as well as North American, European and International regulations/guidelines.   
  • Previous CMC Authoring experience is required.

Preferred Qualifications:

  • MA/MS and/or PhD degree in science, or equivalent experience, preferred. 
  • Demonstrated experience with microbiology, immunology, virology or bacteriology preferred.
  • Ability to manage multiple priorities efficiently.

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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