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Regulatory Affairs Officer - VIE Contract (W/M)

Swiftwater, Pennsylvania

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Overview

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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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

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.

We are looking for a candidate for a VIE mission of:

Regulatory Affairs Officer- VIE Contract (W/M)

Responsibilities

  • Provide support to the Global Regulatory Affairs Business Unit Franchise (GBU).
  • Provide support for the development of product/project-related global regulatory strategy.
  • Provide support for the oversight and prioritization of product/project-related activities.
  • Provide support and assist the Global Regulatory Team-Leader (GRT-L) for preparing for meetings, writing meeting minutes, SHAREpoint organization/maintenance, dashboards, action follow-up.
  • Provide support in consolidating various global information relevant for products or portfolio.
  • Provide support for the preparation of Briefing Packages or other submission components, as necessary.
  • Provide support for the preparation and maintenance of the document inventory for core dossier preparation (= Product Reference File).
  • Provide support for various governance committees and related documents.
  • Provide support for the monitoring of global submissions/approvals status, global oversight of Health Authority commitments, and contribute to Key Performance Indicators (KPI) monitoring.
  • Provide support for the preparation of regulatory information for Periodic Benefit-Risk Evaluation Reports (PBRERS) and Development Safety Update Reports (DSURs).
  • Provide support for the coordination and submission of World Health Organization (WHO)-related submissions, including Quality Control (QC) checks, tracking and archiving activities.
  • Provide support to GRT-L for Investigational New Drug (IND)/Clinical Trial Application (CTA) submissions (document inventory; core dossier preparation).
  • Provide support to GRT-L for meeting preparation with external consultants/experts for product-related matters or Health Authority interactions.

Requirements

Educational background

  • Master’s degree in Pharmacy, Science.

Professional experience

  • 1-3 years of professional experience, preferably within a corporate environment.

Skills

  • Fluent English, excellent writing and editing skills.
  • MS Office applications.
  • Experience with SharePoint, user Relationship Management  (CRM) and Project Management software would be a plus.
  • Good communication skills, ability to interact in a multicultural environment.
  • Ability to analyse business processes for efficiency, scalability.
  • Proven ability to communicate effectively in teams, small groups and in a presentation environment.
  • Driving license.

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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