This role can be based at any of these Sanofi office locations: Swiftwater, PA; Bridgewater, NJ; Cambridge, MA; Framingham, MA; or Meriden, CT.
- Performs change control assessments and manages assigned action items.
- Develops CMC regulatory strategies and risk assessments; provides regulatory advice outside of Regulatory Affairs.
- Author, review, approve and/or contribute to submission-grade documents for project and regulatory files (INDs, CTAs, BLAs, CTDs, etc.) for US, Canada, and International filings.
- Responsible for accurate tracking and management of Health Authority requests.
- Participates on project teams and communicates status to respective Regulatory Affairs members.? Projects may consist of any product phase (Pre-IND through Phase III; post-approval.)? May lead CMC working groups as required.
- Uses time management skills to successfully meet deliverables.? Anticipates delays in pre-defined submissions and either sets up corrective actions plan or proposes alternative solutions.?
- Participate and/or provide support to GMP inspections and preparation.
- Manages contacts among Health Authorities or third parties where CMC related issues/topics are concerned, relevant functions within Industrial Affairs, and project teams.? Sets up necessary meetings among all parties, and negotiate issues between parties as needed.
- Provides input and resources towards the development and implementation of new Regulatory systems, procedures, and/or tools.
- Responsible for staying up-to-date on regulatory guidances and technical/scientific developments.
- Responsible for the day-to-day oversight of Regulatory Affairs CMC contractor staffing.
- Bachelor?s degree with 2+ years of Regulatory Affairs experience; OR Master?s degree in Regulatory Affairs.
- Experience working on Project teams
- 2+ years of Regulatory Affairs CMC experience is strongly preferred
- In-depth knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines, is strongly preferred??
- Ability to manage multiple priorities efficiently is strongly preferred.
- Degree in a scientific field (Biology or Life Sciences)
- Demonstrated knowledge in microbiology, immunology, virology, or bacteriology.
- Minimum of 2 years prior Manufacturing or Quality Assurance experience in the pharmaceutical / biotech industry.
- Previous Regulatory Affairs CMC Authoring
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.
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.