Project Leader Regulatory Affairs - VIE Contract (W/M)
Toronto, Canada
Overview
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Success Profile
Do you have what it takes for a successful career with Sanofi?
- Courageous
- Results-driven
- Proactive
- Problem-Solver
- Leadership
- Team player
Culture: Play to Win
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Growth
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Innovation
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Efficiency
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Collaboration
Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Financial
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Culture
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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Work/Life Balance
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
Quote
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
Shannon Resetich
US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Mouhamed Gueye
US Head Medical Rare Blood Disorders
Responsibilities
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. Please make sure to apply with your personal email address.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.
We are looking for a candidate for a VIE mission of:
Project Leader Regulatory Affairs - VIE Contract (W/M)
Target start date: 01/07/2024
Your responsibilities:
- Lead address change project
- Support ongoing and new labelling safety updates, clinical trial application
- Support Regulatory Affairs (RA) Head and Project Leaders in the preparation of New Drug Submissions (NDSs) and new indication supplements
- Lead new indication supplements, where applicable
- Support Clinical Trial Applications (CTAs), where applicable
- Support new initiatives or Health Canada pilot projects, where applicable
- Develop and execute filing and approval strategies
- Organize and coordinate meetings with Health Canada
- Assure the quality and timeliness of regulatory submissions in electronic Common Technical Document (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
Key “MUST HAVE” competencies, skills & experiences:
- Master’s degree in pharmacy or other life science discipline such as Biology, Medicine, Chemistry, etc. is preferred
- Experience at least 1 – 2 years of experience in regulatory affairs would be an advantage
- IT skills: Proficiency in MS Office package and databases
- Strategic mindset
- Good project management and organizational skills
- Accurate and precise working attitude
- Strong time management and prioritization skills
- Ability to work cooperatively with others across (multifunctional and multicultural) the organization to achieve shared objectives
- Fluent English & French
- Open-minded and appetite to challenge status quo.
- Strong interpersonal skills
Pursue progress. Discover extraordinary.
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.
