Sanofi Group Manager Regulatory Affairs - Swiftwater, PA in Swiftwater, Pennsylvania
Collaborates on CMC regulatory strategies and risk assessments; and is comfortable providing regulatory advice internally, as well as in a team environment.
Author, review, approve and/or contribute to submission-grade documents for projects and regulatory files (INDs, CTAs, BLAs, CTDs, etc.) . Can be associated with US, Canada, and/or International filings.
Responsible for accurate tracking and management of Health Authority requests, this includes educated follow-ups with regional regulatory affairs and/or affiliates as necessary.
Is able to clearly communicate status updates to respective global regulatory affairs colleagues, so that dissemination of information at project team level is accurate and clear. Projects may consist of any product phase (Pre-IND through Phase III; post-approval.) Will also assist in 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 for discussion.
Provide support to GMP inspections and preparation as requested.
Is aware of on-going Health Authorities activities / negotiations where CMC related issues/topics are concerned. This may also entail communication with internal functions i.e. industrial affairs, and project teams to seek updates and/or information for health authority responses and/or meeting. This role may / may not participate in Health Authority contact activities.
Sets up necessary meetings internally among cross-functional parties and is able to negotiate issues between parties as needed / requested.
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.
Bachelor’s degree with 2+ years Regulatory Affairs experience OR Master’s degree in Regulatory Affairs
Requires in depth knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines.
Ability to manage multiple priorities efficiently.
Ability to communicate effectively on complex topics.
Effective writing abilities
Experience working on project teams and/or cross-functionally within a professional environment.
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.