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Regulatory Affairs Project Leader - VIE Contract (W/M)

Laval, Canada

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Job ID R2523274 Date posted 11/15/2019

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 Affairs Project Leader - VIE Contract (W/M)

Responsibilities:

  • Provide regulatory strategic input to local and global teams for product in development and marketed products throughout their life-cycle
  • Develop and execute filing and approval strategies
  • Organize and coordinate meetings at Health Canada
  • Assure the quality and timeliness of regulatory submissions in eCTD format and approvals
  • Ensure maintenance of compliance for marketed products with a focus on product monographs and drug labels
  • Review promotional and non-promotional material to ensure compliance
  • Occasionally, travel to Ottawa/Bridgewater offices

Requirements:

  • Education: Master in pharmacy or any health-related field; good understanding of the current Health Canada regulations and guidelines regarding pre-clinical, clinical or chemistry and manufacturing issues is a plus
  • Experience: at least 1 year of previous experience in the preparation of regulatory submissions
  • Soft skills: action-oriented, dealing with ambiguity, leadership skills, negotiating, priority setting, process management, standing alone, strategic agility and team work
  • Languages: fluent English and French (written and spoken) 
  • IT tools: MS Office (Outlook, PowerPoint, Word, Excel); MS Project is optional; Adobe Acrobat is a must

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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