Manager, Regulatory Site Office (RSO) - Vaccine
OVERVIEW OF THE POSITION
The Regulatory Site Office Manager, Vaccines will work closely with the Manufacturing and Supply teams, and CMC colleagues on projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing
The RSO Manager supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater. They manage regulatory activities linked to change controls for the site, including the update of CMC files. They are accountable for product license maintenance and site registrations. They provide support to batch release by checking submission/approvals, ensuring permanent regulatory/license compliance by maintaining product license commitment documents.
DUTIES AND RESPONSIBILITIES
Has the responsibility of one or several Transversal Activities. For these activities, the RSO member acts as a Single Point of Contact for the coordination of related requests emanating from both local and global Manufacturing & Supply and Regulatory Affairs.
Provides support to batch release by checking submission/approvals, ensuring permanent regulatory/license compliance and authoring, reviewing, and approving site documents (e.g. Product License Commitments).
Manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports.
Prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.
Provides the initial regulatory expertise to site projects and evaluates the potential regulatory impact of Swiftwater change control requests, and supplier change notifications.
Serves as an interface between M&S and GRA. The RSO Manager communicates Regulatory requirements to the site and may represent RSO for inspection readiness activities and/or in physical / virtual inspections taking place with Health Authorities and/or governing bodies
May represent RSO on M&S project teams when regulatory site expertise is required.
Main focus/challenge will be on the appropriate planning, prioritization, and coordination of activities among M&S functional areas and with Regulatory Affairs groups, and for timely identification and communication of project/product related concerns to the upper management such that they can be addressed/resolved in a timely manner.
Personal Development / Training: Responsible for staying up-to-date on regulatory guidance and technical/scientific developments. Assesses impact on areas of responsibilities, communicates to organization and, comments on draft regulations and assesses future areas for influencing the regulatory environment.
Education / Experience
Bachelor’s degree with 2+ years Regulatory Affairs or an appropriate combination of other relevant industry experience e.g., Quality and/or Manufacturing
Knowledge, Skills and Competencies
Strong Authoring skills of CMC documentation and Health Authority responses
Should demonstrate initiative, analytical thinking and works independently
Ability to work well with cross functional teams, and good communication skills with internal and external stakeholders
Experience working on Project teams and the ability to manage multiple priorities efficiently
Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and
trends are helpful but not essential.
Technical and regulatory requirements related to CTD
Familiarity with ICH guidelines, and Pharmacopoeias
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.