Managed Services Specialist
Canada, Ontario
Fulltime: 40 hrs a week
Experience: 2-4 Years
Pharmaceuticals
Managed Services Specialist, Regulatory Affairs (renewable contract)
Remote - Ontario or Quebec
Job Descriptions
Responsibilities
- File regulatory submissions (from the company's portfolios) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels.
- Update required the company's internal systems and databases with regulatory affairs information, as per their SOP's such as Vault RIM.
- Communicate and work with the company's local (eg, Canada brand team) and global stakeholders, according to their SOPs.
- Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada.
- Interact directly with Health Canada, and to address questions on filed submissions to ensure approval.
- Create detailed Yearly Biologic Product Reports (YBPR) by gathering data from the CPID, following regulatory guidelines and coordinating communication with key stakeholders.
- Oversee and coordinate the submission of Public Release of Clinical Information (PRCI), ensuring clear communication with internal teams and Health Canada.
Job Requirements
- Requirements
- Bachelor degree in pharmacy or any health-related field.
- Minimum of 1-3 years previous experience in the preparation of regulatory submissions specific to innovative drugs.
- English (written and spoken), French is an asset.
- Good understanding of the current Health Canada regulations and guidelines (CMC, clinical, and labeling).
- Good team work and ability to work independently.
- Computer knowledge of Microsoft Office Suite; Adobe Acrobat.
- Organised, attention to detail and deadline driven.