Sanofi Group Regulatory Affairs Officer - VIE Contract (W/M) in Swiftwater, Pennsylvania

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

PLEASE NOTE that since the VIE 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.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.

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

Regulatory Affairs Officer - VIE Contract (W/M)

Job Details:

  • 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

Candidate:

Educational background:

Master’s degree in Pharmacy, Science

Professional experience:

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

Skills:

  • MS Office applications

  • Experience with Sharepoint, CRM and Project Management software would be a plus

  • Fluent English, excellent writing and editing skills

  • Good communication skills and facilitation skills, ability to interact in a multicultural environment

  • Ability to analyze business processes for efficiency, scalability

  • Proven ability to communicate effectively in teams, small groups and in a presentation environment

  • Excellent writing skills, editing skills, excel, power point and organizational skills

  • Ability to analyze business processes for efficiency, scalability

  • Proven ability to communicate effectively in teams, small groups and in a presentation environment

  • Experience with CRM

  • Project Management softsafe

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life