Project Leader Regulatory Development- Mississauga/ON
Sanofi, in the U.S. and Canada, strives to create a diverse and inclusive work environment that empowers employees to drive their careers and be successful. The talent we look for will contribute to the organization in innovative, insightful, and creative ways in order to strengthen our dynamic culture and drive us collectively to make a difference in the lives of patients.
HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
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
- Bachelor degree in pharmacy or any health-related field
- 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
- English: Advanced – Excellent knowledge
- French is considered an asset
- MS Outlook, PowerPoint, Word, Excel, WordPerfect, MS Project, Adobe Suite
- 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.
Sanofi, Empowering Life
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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