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Regulatory Site Officer External Supply QA

Waltham, Massachusetts

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Overview

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Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Leadership
  • Proactive
  • Problem-Solver
  • Results-driven
  • Team player

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Culture: Play to Win

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    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

POSITION OVERVIEW

Regulatory Site Officer External Supply QA​

Core Responsibilities

  • 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

Additional Responsibilities

  • 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

Leadership Qualifications

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.

Basic Qualifications

  • 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.

Preferred Qualifications

  • 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.

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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.

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