Senior Regulatory Affairs Associate
On-siteLaval, Quebec, Canada
Job Summary
Prepare, review, and submit CTAs, INDs, and exemption applications to Health Canada and FDA for small drug molecules, biologics, and combo products. Conduct gap analysis on regulatory documents, write Quality Overall Summaries (QOS), and manage responses to agency information requests. Liaise with regulatory agencies to ensure expectations are met, maintain submission databases, and track amendments, notifications, and annual reports. Prioritize workload to meet delivery deadlines while staying current on Health Canada, FDA, and ICH guidelines. Bachelor's degree in Life Sciences with two years of regulatory experience required; Master's preferred. Fluency in English is essential.
Required Qualifications
- Bachelor's degree in Life Sciences
- Minimum of 2 years of related experience
- RACS certification
- Strong computer skills (MS Word, Excel, Outlook and Power Point)
- Ability to understand and adapt to various information technology (IT) systems
- Ability to read and interpret technical documents and industry specific manuals
- Ability to write advanced reports and correspondence
- Ability to speak effectively before groups of customers or employees of the organization
- Excellent verbal and written communication skills
- Critical thinking skills and ability to acquire and apply knowledge quickly
- Professional attitude and strong interpersonal skills
- Ability to work well with a multi-disciplinary team of professionals
- Client-focused approach to work
- Flexible attitude with respect to work assignments and new learning
- Ability to prioritize workload
- Thorough understanding of clinical research, drug development process and applicable regulatory guidance
- Fluency in English
Desired Qualifications
- Master's degree
- Minimum of 2 years of related experience, in a regulatory field preferred
- French working environment
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