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Regulatory and Projects Coordinator - VIE Contract (W/M)

Bridgewater, New Jersey

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Job ID R2514288 Date posted 09/02/2019

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:

Regulatory and Projects Coordinator - VIE Contract (W/M)

The candidate should have a basic understanding of the Common Technical Document (CTD), learned didactically or through hands-on experience, and at least 1-2 years of regulatory experience.  Some Chemistry, Manufacturing, and Controls (CMC) experience is desired, but not mandatory.  Excellent communication skills is necessary.  A basic understanding of change controls is desired.  Some understanding of local and regional regulatory guidelines is desired.  Knowledge of MS Office, Word, Excel and electronic document management systems.   A working knowledge of cGMP’s is desired.  A Master of Science (MSc) degree from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).

This position requires the incumbent to be highly organized, self-motivated, and able to manage multiple priorities.  The desired candidate will have the capacity to be productive with minimal supervision.  Excellent interpersonal communication and collaboration skills are required. Knowledge of the US regulatory processes and exposure to non-US regulatory activities is a plus.

Responsibilities:

  • Author and compile Chemistry and Manufacturing Control (CMC) submissions
  • Work closely with quality, manufacturing, regulatory and technical staff throughout global Sanofi locations and external manufacturers to communicate, coordinate and track required documentation in support of CMC submissions
  • Author and creator of dossier content from source documentation as needed for CMC content of submissions and provide writing support for technical reports
  • Recommend table of contents for regulatory submissions
  • Ensure all dossiers are in compliance with appropriate Standard Operating Procedures (SOPs), Good Practice (GXP) and International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance and maintain up to date knowledge
  • Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions
  • Develop and maintain skills required for dossier related software systems used and included in regulatory filings

Requirements:

Education:

  • Master of Science degree in Biology, Analytical Chemistry, Pharmacy or other relevant field

Experience:

  • A minimum of 1 year of previous regulatory experience
  • At least basic understanding of the Common Technical Document (CTD), learned didactically or through hands-on experience

IT skills:

  • Good working knowledge of MS Office sutie
  • Basic understanding of Electronic Document Management Systems (ie. Documentum or Veeva)

Language:

  • Fluent English

Other desirable skills:

  • Previous Chemistry, Manufacturing, and Controls (CMC) experience
  • Experience with change control systems
  • Some understanding of local and regional regulatory guidelines
  • Working knowledge of Good Manufacturing Practice and Code of Federal Regulations (CFR) is desired
  • Excellent communication and technical writing skills
  • Knowledge of the US regulatory processes and exposure to non-US regulatory activities is a plus
  • Basic understanding of writing templates and template tools

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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