Regulatory Affairs Specialist
3 days ago
We are seeking a skilled Regulatory Affairs Specialist to join our team at Baxter, a leading healthcare company dedicated to saving and sustaining lives. This role will play a critical part in ensuring compliance with regulatory requirements for our products in Canada.
About the Role:
This position involves working under limited supervision to implement regulatory strategies, obtain and maintain marketing authorizations for products, and communicate local regulatory requirements to support licensing of our products. The successful candidate will have experience in preparing submissions according to current Health Canada requirements and collaborating with stakeholders to provide timely responses.
Your Responsibilities Will Include:
- Preparing submissions of increasing complexity, including NDS, SNDS, Medical Device Applications, CTAs, etc., according to current Health Canada requirements
- Collaborating with key stakeholders to provide accurate and timely responses to Health Canada
- Participating in driving compliance with the quality system within Regulatory Affairs
- Organizing and maintaining regulatory documents in a format consistent with current RA practices and Baxter processes
What You'll Bring:
To be successful in this role, you will need a Bachelor's degree or equivalent in a scientific discipline and a minimum of 2 years' experience in regulatory affairs within a pharmaceutical and/or medical device company. Strong project management skills, ability to multitask and prioritize effectively, and excellent interpersonal and communication skills are essential. Knowledge of regulations and compliance requirements, as well as scientific knowledge and technical skills, are also required.
Estimated Salary Range: $80,000 - $110,000 per year
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