Project Leader Regulatory Development- Mississauga/ON

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City : Mississauga

Category : Regulatory Affairs, Sanofi Genzyme, Diabetes and Cardiovascular, General Medicines and Established Markets, Specialty Care

Industry : Pharmaceutical

Employer : Sanofi

POSITION SUMMARY

Accountable for the attainment of development products and marketed products objectives.

KEY RESPONSIBILITIES AND DUTIES FOR THIS JOB

  • To provide regulatory strategic input to local and global teams for product in development and marketed products throughout their life-cycle
  • To develop and execute filing and approval strategies
  • To organize and coordinate meetings at Health Canada
  • To assure the quality and timeliness of regulatory submissions in eCTD format and approvals
  • To ensure maintenance of compliance for marketed products with a focus on product monographs and drug labels
  • To review promotional and non-promotional material to ensure compliance

KEY REQUIREMENTS FOR THIS JOB

EDUCATION

  • Bachelor degree in pharmacy or any health-related field

EXPERIENCE

  • Minimum of 5-7 years previous experience in the preparation of regulatory submissions

SPECIFIC SKILLS AND/OR COMPETENCIES

  • Essential: Good understanding of the current Health Canada regulations and guidelines regarding pre-clinical, clinical or chemistry and manufacturing issues
  • Special: Action-oriented, dealing with ambiguity, leadership skills, negotiating, priority setting, process management, standing alone, strategic agility and team work

LANGUAGES

  • English: Advanced – Excellent knowledge
  • French is considered an asset

COMPUTER KNOWLEDGE

  • MS Outlook, PowerPoint, Word, Excel, WordPerfect, MS Project, Adobe Suite

TRAVEL

  • Occasionally (mostly to Ottawa, occasionally to US, Europe or Canada)

About Sanofi – www.sanofi.ca

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 entities in Canada include the Diabetes and Cardiovascular Care Business Unit, the General Medicines and Established Products Business Unit, Sanofi Pasteur (vaccines), Sanofi Genzyme (specialty care) and Sanofi Consumer Health. Together they employ close to 1,900 people. In 2015 Sanofi companies invested $133.3 million in R&D in Canada, creating jobs, business and opportunity throughout the country.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Follow Sanofi Canada on Twitter: @SanofiCanada  and on YouTube: youtube.com/user/sanoficanada

Sanofi, Empowering Life

#GD-SA #LI-SA

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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