Responsibilities:
• Compile and submit, in a timely manner, regulatory documents in compliance with current Health Canada regulations and guidelines for drugs, biologics and or medical devices.
• Maintains all scientific, medical, clinical and manufacturing documentation for the registration of products/devices in a timely and thorough manner.
• Recommends, prepares and review changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.
• Verifies compliance with the Food and Drug Act and Regulations and works with manufacturers to maintain compliance with regulatory submissions for all products and devices.
• Lead, coordinate responses to regulatory authorities and clarify/questions within strict deadlines.
• Participate and support TPD meetings as required.
• Able to develop submission strategies and identify compliance risks. Recommends strategies for earliest possible approvals of submissions
• Maintains close communications and a good working relationship with both Canadian and Global Regulatory, Quality and Legal Departments to ensure that regulatory complaints/deficiencies, issues or concerns are efficiently concluded.
• Provides direction to product managers and manufacturers to ensure that products, advertising and labeling comply with regulations developed by Health Canada.
• Participate as an active team member and provide regulatory advise on Global Product Teams as required.
• Develops and or review Regulatory Project Plan and all pertinent information required in the drug approval process to meet Canadian Regulation requirements.
• Keep abreast of Regulatory Development and changes in the Industry
Job Requirements
• B.Sc, preferably an MSc.
• Minimum 4-6 years Regulatory experience.
• Excellent Scientific knowledge
• Excellent written and verbal Communication skills
• Extremely organized
• Time Management
• Manage Multiple projects and deadlines
• Ability to identify compliance risks and escalate as required
• Word/MS Project and database management skills
• French or other language
• Ability to travel
Percent Travel Required 5%
We thank all applicants for their interest; however only those individuals selected for an interview will be contacted.
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