The Regulatory Affairs Associate is responsible for obtaining Drug, Medical Devices and Natural Health Product registrations with Health Canada. The incumbent is responsible to ensure that all current products are in compliance with Health Canada. The Regulatory Affairs Associate will support internal management. The role is flexible; can be Full Time or Part Time
Skills & Experience
- The successful candidate is a highly motivated, enthusiastic and dynamic team player who is resourceful and dedicated and has competencies in adapting to changing environments.
- University Science Degree and/or RA Diploma with at least three years of previous Regulatory Affairs experience is required
- Must have experience with e-CTD Submissions (NDS, S/NDS)
- Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
- Extensive Knowledge of Canadian GMPs
- Applies good document management practices.
- Solid working knowledge of Pharmacovigilance
- Working knowledge of eCTD structure and requirements
- Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
- Excellent communication skills(written and oral)
- Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
- The successful Candidate will possess excellent attention to detail and have the ability to manage time and complex RA projects.
Specific responsibilities include:
- Assumes primary responsibility for the preparation, compilation, notification, amending and submissions of Drugs, Medical Devices and Natural Health Products to Health Canada
- Ability to Interpret clinical, scientific data and information
- Respond to requests from Health Canada – clarification for new submissions and compliance for existing products.
- Ensure all HC requirements and deadlines are met as it relates to annual drug notifications, Site License and DEL renewals.
- Support in preparing for regulatory inspections, participate in internal and regulatory audits as required and execute the necessary corrective actions
- Maintain Standard Operating Procedures; Review of documentation for GMP purposes
- Evaluate complaint reports for accuracy and maintain a Phamacovigilance system
- Work with local and foreign site organizations on GMP matters to resolve issues as needed
- Provide technical and regulatory advice and support to the Business Development Team
- Ensure that product labelling and monograph are accurate and compliant
- Assist in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations
If this opportunity is of interest to you and are looking to working in a small company with growth opportunities, we would like to speak to you. Please include your salary expectations.
Only those with experience with e-CTD Submissions need apply.
While we appreciate the interest of all applicants, only candidates selected for an interview will be contacted.