Sanofi Group Regulatory Site Officer External Supply QA in Waltham, Massachusetts
Regulatory Site Officer External Supply QA
Acts as a focal regulatory interface between the external and internal manufacturing sites, quality units, MSAT, Global Regulatory Affairs and Sanofi affiliates
Collaborates closely with Specialty Care External Supply personnel in order to ensure compliant manufacturing and release operations
Manages CMC dossiers, variations, renewals, annual reports, site registrations and territory extensions as part of regulatory product lifecycle management responsibility
Reviews and approves cGMP or regulatory reports / change controls / protocols/ submissions and associated action plans in order to ensure regulatory and cGMP compliance
Analyses complex regulatory issues and processes and applies own professional knowledge to identify key areas of risk to compliance with registered details
Acts as a source of technical expertise for others and gives advice on own area to other functions and employees
Frequent inter-departmental, inter-organizational and external interactions
Support the development and management of quality agreements between Sanofi and the contractor
May lead internal regulatory assessment of information to support internal or external audits and supplier qualification as required
Support program for maintaining performance metrics
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Excellent regulatory and cGMP knowledge.
Good communicator and project manager
Attention to detail
Good organizational skills
Lead by example
Proven ability to work across functions and cultures
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Bachelor’s degree with scientific background or equivalent and 5+ years of experience in a GxP or regulatory affairs environment.
Master’s degree with scientific background and 3 years of experience in a GxP or regulatory affairs environment, to include 2 years in a regulatory affairs role.
In-depth understanding of quality and regulatory systems and management tools.
Broad knowledge and experience of EU/US GMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs.
A working knowledge of conventional and biotechnological manufacturing operations, aseptic processing, validation principles, quality control techniques and testing methodologies of drug substances and drug products is beneficial.
Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
Strong written and verbal communication and project management skills and the ability to multitask effectively.
Problem solving and technical writing skills.
Willingness to travel
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.