Clinical Trial Application Manager
Reference No. R2716173
Position Title: Clinical Trial Application Manager
Location: Mississauga, Ontario
About Sanofi Specialty Care
Sanofi's specialty care business unit focuses on rare diseases, rare blood disorders, neurology, immunology, and oncology. Sanofi's ambition is to leverage science and innovation to improve people’s lives and be the industry leader in immunology and oncology. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
This position is primarily responsible for the Regulatory Affairs project management and submission of initial Clinical Trial Applications (CTAs), amendments, responses, and updates.
Collaborate with internal cross-functional teams (eg. Regulatory, Regulatory CMC, Clinical, etc.) to ensure high-quality regulatory submission of initial CTAs, amendments, responses, and updates.
Ensure pre-CTA meeting requests, initial CTA applications, and maintenance of CTAs through the duration of clinical studies are in alignment with internal defined strategies to meet agreed upon timelines and in compliance with Health Canada (HC) Regulations and issued due dates. Ensure clinical supply labels adhere to local regulations.
Maintenance of internal databases updates in timely manner as required.
Provide Regulatory CTA expertise in support of clinical study feasibility and start up activities as needed.
Oversight and accountability for study-related submission activities for electronic Trial Master File (eTMF).
Support corporate audits and HC inspections of study sites as necessary.
Maintain awareness and knowledge of new and changing CTA requirements.
University degree in Health Sciences
Minimum 2 years of experience in Regulatory Affairs.
Self-motivated, action and result oriented
Excellent negotiation, communication, and strong interpersonal skills
Good organization and planning skills.
Ability to multitask and manage ambiguity/versatility
Strong knowledge of drug development, clinical study management, Health Canada requirements, ICH, GCP, site management and monitoring
Experience in the pharmaceutical industry in drug development including clinical research and Regulatory Affairs
English (written and spoken)
French is an asset
MS Outlook, Word, Excel, PowerPoint, Adobe Acrobat
Veeva Vault database familiarity is an asset
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!
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.
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.