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COMPLETE Global Regulatory Affairs Associate - VIE Contract (W/M) - Swiftwater, PA

10 days ago


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Job Opportunity Details

Type

Full Time

Salary

Not Telling

Work from home

No

Weekly Working Hours

Not Telling

Positions

Not Telling

Working Location

Swiftwater, PA, Pennsylvania, United States   [ View map ]

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.

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: Global Regulatory Affairs Associate - VIE Contract (W/M)

Target start date: 01/11/2023

Responsibilities:

  • Coordinate regulatory activities to support the Global Submission Plan with the global product regulatory team (GRT), track and update Global Simultaneous Submission plan (GSS)
  • Coordinate regulatory activities to support the product lifecycle or development plans
  • Participate in the preparation of consultations with authorities
  • Support the Global Regulatory Lead (GRL) in reference to product regulatory team (GRT) meetings composed of different regulatory experts (RegCMC, RegLabeling, Regional Regulatory contacts, Regulatory Operations) : preparation, meeting minutes, follow-up of actions
  • Develop the document summarizing the Global Regulatory Product Strategy (GRPS)

Requirements:

  • PhD, Pharm D or DVM or MSc in Biology, Life Science, or related field of study, Master of Science in Regulatory Affairs
  • 1 year of previous fill-time working experience preferably in Regulatory Affairs
  • Pharmaceutical industry experience is preferred
  • You can demonstrate solid English oral communication, presentation and writing skills
  • You have solid knowledge of MS Office software, knowledge of Think-Cell would be a plus
  • You are rigorous and known for your analytical and synthesis skills
  • You are motivated and open-minded, you like working in a team and interacting on cross-cutting and multicultural subjects
  • You have a solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy
  • You have an unquestionable ethics, professional integrity, and personal values consistent with Sanofi values

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.


More Information

Application Details

  • Organization Details
    (2605) Sanofi Pasteur Inc.
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