Regulatory Compliance Specialist II (RSO) –Remote (contract)
Sanofi, Swiftwater, PA, United States
Job Description
Sanofi's contingent workforce program, FLEXT Direct, is seeking a Regulatory Compliance Specialist II for a 6-month contract likely to extend. The RSO Specialist will work closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines projects. The main focus of this position will be to support a Veeva Vault RIM project, requiring previous regulatory and Veeva Vault experience. The RSO Specialist will be the main project contact with support from the local RSO team. Responsibilities will include testing and project support. Note: This role is focused on Regulatory Compliance and CMC activities and is not a computer system validation (CSV) role. The emphasis is on ensuring data accuracy, alignment, and regulatory compliance within systems. Key Responsibilities
Ensure regulatory compliance by supporting batch release Check submissions/approvals Ensure ongoing regulatory/license compliance Review and approve site documents (e.g., SOPs, Site Master File, Product License Commitments) Manage review, assessment, and coordination of submission requirements for changes proposed by the M&S organization Participate in meetings and follow-up activities to ensure proper assessment of change controls Author CMC regulatory documents (Modules 1.2, 2.3, and 3) to support: Marketing Authorizations Site registrations Country-specific documentation Annual reports Prepare responses to Health Authority questions related to CMC with input from site experts Represent RSO on M&S and MSAT project teams when needed and serve as the Regulatory interface between M&S, MSAT, and GRA Qualifications
Bachelor’s Degree required (Master’s accepted) 2–6 years of experience Experience in pharmaceutical/biopharmaceutical or related regulatory/manufacturing environment Well-developed written and verbal communication skills Required Skills
Previous Veeva Vault RIM experience Strong regulatory compliance background Strong authoring skills (GMP and CMC documentation, Health Authority responses) Knowledge of GMP (Good Manufacturing Practices) Ability to manage multiple priorities efficiently Ability to resolve technical and regulatory issues Demonstrated initiative, analytical thinking, and ability to work independently Strong collaboration skills; ability to work cross-functionally with internal and external stakeholders Preferred Skills
Experience performing User Acceptance Testing (UAT) for systems (supporting role; not validation-focused) Experience working with Health Authorities Knowledge of global regulations, guidelines, and industry trends Additional Information
100% remote 6 month contract likely to extend beyond October (may support a different project upon extension)
#J-18808-Ljbffr
Sanofi's contingent workforce program, FLEXT Direct, is seeking a Regulatory Compliance Specialist II for a 6-month contract likely to extend. The RSO Specialist will work closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines projects. The main focus of this position will be to support a Veeva Vault RIM project, requiring previous regulatory and Veeva Vault experience. The RSO Specialist will be the main project contact with support from the local RSO team. Responsibilities will include testing and project support. Note: This role is focused on Regulatory Compliance and CMC activities and is not a computer system validation (CSV) role. The emphasis is on ensuring data accuracy, alignment, and regulatory compliance within systems. Key Responsibilities
Ensure regulatory compliance by supporting batch release Check submissions/approvals Ensure ongoing regulatory/license compliance Review and approve site documents (e.g., SOPs, Site Master File, Product License Commitments) Manage review, assessment, and coordination of submission requirements for changes proposed by the M&S organization Participate in meetings and follow-up activities to ensure proper assessment of change controls Author CMC regulatory documents (Modules 1.2, 2.3, and 3) to support: Marketing Authorizations Site registrations Country-specific documentation Annual reports Prepare responses to Health Authority questions related to CMC with input from site experts Represent RSO on M&S and MSAT project teams when needed and serve as the Regulatory interface between M&S, MSAT, and GRA Qualifications
Bachelor’s Degree required (Master’s accepted) 2–6 years of experience Experience in pharmaceutical/biopharmaceutical or related regulatory/manufacturing environment Well-developed written and verbal communication skills Required Skills
Previous Veeva Vault RIM experience Strong regulatory compliance background Strong authoring skills (GMP and CMC documentation, Health Authority responses) Knowledge of GMP (Good Manufacturing Practices) Ability to manage multiple priorities efficiently Ability to resolve technical and regulatory issues Demonstrated initiative, analytical thinking, and ability to work independently Strong collaboration skills; ability to work cross-functionally with internal and external stakeholders Preferred Skills
Experience performing User Acceptance Testing (UAT) for systems (supporting role; not validation-focused) Experience working with Health Authorities Knowledge of global regulations, guidelines, and industry trends Additional Information
100% remote 6 month contract likely to extend beyond October (may support a different project upon extension)
#J-18808-Ljbffr