We are currently seeking a full-time temporary (12 months) Senior Regulatory Associate New Product Development and Medical Devices to join our team! Hybrid role, on-site requirement 3 days/week Location - 165 Galaxy Blvd., Toronto ON (Pearson Airport Area) The pay range for this role is: $90,000.00 - $100,000.00. Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities.
This position is an existing vacancy within the organization.
MAIN RESPONSIBILITIES - Participates actively in project team meetings and provides Canadian regulatory requirements to the respective functions within the project team in accordance to the current Health Canada and ICH requirements
- Compiles and submits regulatory dossiers (e.g. NDSs, ANDSs, SNDSs, SANDSs, and other applications) or medical device regulatory applications in accordance to the current Health Canada guidance documents as required
- Conducts accurate regulatory assessment for post-approval changes for pharma and devices and identifies level of filing and data requirements
- Communicates with internal and external stakeholders to obtain application documents
- Supports the Quality and Marketing Departments in the change control and product launch processes as required
- Manages own projects independently as per assigned deadline and reports any delays to management
- Provides regular reports to management on the status of regulatory submissions, licenses/clearances and registrations
QUALIFICATIONS - Bachelor of Science Degree in one of Chemistry, Microbiology, Biology, Pharmacology or other life science is required at minimum
- Completion of a college regulatory affairs program is an asset
- Minimum of four years of pharmaceutical experience in a regulatory affairs capacity for pharma and/or medical devices
SKILLS - Strong knowledge of chemistry and manufacturing requirements for pharmaceuticals
- Strong knowledge of Health Canada Medical Device regulations and understanding of global regulatory requirements
- Strong communication skills (written and verbal)
- Able to understand customer needs and the ability to collaborate both inside and outside the organization
- Strong computer skills in Microsoft Office 365• . Adobe Acrobat and familiarity with eCTD Document Management System are required.
- Strong attention to detail
- Self-motivated
- Proven ability to adhere to standards and procedures and maintain confidentiality
- Strong commitment to quality and accuracy
- Analytical skills to assess problems and present solutions are required
- Ability to work well under pressure in a team-based environment
