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Senior Regulatory Affairs Associate
On behalf of our client, we are looking for a Senior Regulatory Affairs Associate for a remote position. The Senior Regulatory Affairs Associate will be responsible for managing submissions and responses for the company’s products with Canadian regulatory agencies. They must have a high attention to detail, the ability to work independently, and have an understanding of Canadian pharmaceutical regulations.
- Evaluate and prepare drug product submissions for Health Canada, while ensuring that submissions are accurate and meet format and content requirements.
- Evaluates changes and prepares subsequent filings to ensure regulatory compliance.
- Contribute to the creation and implementation of regulatory strategies throughout the product life cycle.
- Review, evaluate, prepare, and file deficiency responses to Health Canada.
- Interpret scientific data and conclusions from CMC reports and summaries.
- Conduct regulatory reviews of product labelling to comply with requirements.
- Attend, organize, and facilitate meetings and teleconferences with external partners and internal stakeholders to maintain progress of projects. Track and communicate critical attributes of projects to ensure accountability and efficiency.
The Ideal Candidate Brings:
- A University degree in Sciences and a post-graduate certification in regulatory affairs.
- At least 4 years of experience preparing drug submissions for Health Canada.
- Experience working with eCTD submission software.
- Strong teamwork, communication, and organizational skills.
- Ability to work with shifting priorities and on multiple projects.
For additional details, please contact Cynthia McCutcheon at Summit Search Group directly: [email protected] or call 902 405 3607
Please note that only those candidates who fulfill the requirements will receive a response.
Summit Search Group is a fair and equitable search firm. We welcome and encourage applications from all candidates regardless of ethnicity, race, religious beliefs, disability, age, gender identity, or sexual orientation. Accommodations are available on request for candidates taking part in all aspects of the recruitment and selection process.