- University Degree in Science or Life Sciences and post-graduate certification in Regulatory Affair
- Must have a minimum of 5 years of direct experience with CMC modules of drug submissions.
- Experience working with and following Health Canada regulations
- University Degree in Science or Life Sciences. Post-graduate certification in Regulatory Affairs program is an asset.
- 5+ years of direct experience with CMC modules of drug submissions. Experience with product life-cycle management is an asset.
- Strong analytical skills with the ability to critically assess scientific data.
- Knowledge of GMP requirements and QA/QC procedures.
- Strong understanding of Canadian regulatory guidance documents and policies, as well as ICH guidelines.
- Proficient computer skills, including MS Office applications and Adobe Acrobat. Experience with eCTD tools is an asset.
- Working knowledge of French is an asset.
Senior Regulatory Affairs Specialist - Post ApprovalToronto, ON, Canada
Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit www.kellyscientific.com to learn more and view a full listing of our opportunities.
SENIOR REGULATORY AFFAIRS SPECIALIST - POST APPROVAL
The Regulatory Affairs Specialist - Post Approval will be responsible for management and oversight of regulatory aspects of the post-approval program.
Review proposed post-approval changes and the resultant change controls and prepare the regulatory submissions for products in order to fulfill regulatory requirements. Interpret regulatory requirements, provide input into strategic planning, and manage the applicable filings/notifications to maintain compliance and supply.
Oversight of regulatory aspects of the product life-cycle management program.
Follow up on potential post-approval change notifications.
Evaluate post-approval CMC and labelling changes, and any change controls.Reviews scientific information to ensure that the proposed post-approval changes are adequately supported and acceptable for implementation for the Canadian market.
Prepares and submits post-approval submissions to Health Canada (e.g. SANDs, post-approval DINAs, annual notifications). Ensures that submissions are accurate and meet format and content requirements. Peer review of submissions as required.
Prepares and files deficiency responses to Health Canada.
Monitors landscape for changes in regulatory or compendial requirements that may impact products in the commercial portfolio.
Liaises with partners to collect documents and information for post-approval submission preparation or in response to technical queries/deficiency letters.
Maintains current awareness of Canadian and ICH regulatory guidelines and shares knowledge with the department.
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001412
Date Posted: 08/08/2019