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Quality and Regulatory Affairs Associate - VIE Contract (W/M)

Bridgewater, New Jersey

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Job ID R2527174 Date posted 12/05/2019

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:

Quality and Regulatory Affairs Associate - VIE Contract (W/M)

Responsibilities:

Sanofi Active Ingredient Solutions Regulatory and Quality Affairs US ZONE maintains 63 US DMFs (Drug Master Files) that requires a significant amount of maintenance activities such as:

  • Review and publishing of Annual Reports
  • Review and publishing of Amendments (Administrative and Technical)
  • Assessing Change Controls
  • Respond to US Regulatory Affairs customer requests
    • Log and track all customer request into our customer portal (QERiS)
    • Hold customer meetings as requested
    • Hold sales and Regulatory Affairs /Quality Assurance weekly meeting to track progress of customer requests
  • Respond to Food and Drug Administration (FDA) Deficiency Letters
    • Hold meeting(s) with site to discuss content of letter if needed
    • Hold meeting(s) with customers affected by the deficiency letter if requested
    • Coordinate with the site timelines to respond to FDA deficiency letter
  • Send and track Information Letters to each Customer
  • Regulatory Intelligence
    • Alert and inform sales managers and Business Unit (BU) manager of US governmental policies, FDA guidance and trends that may affect our US business
    • Provide training to site and BU managers

Requirements:

  • MS in chemistry, biology, biochemistry, pharmacy or related scientific field
  • At least 1 year of professional experience in field related to the position
  • Must possess sound interpersonal and information gathering skills, being able to relate well to others and have the ability to work in a team environment, effectively interacting with others
  • The individual must have good English communication skills both verbal and written and project management skills
  • Driving Licence

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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