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Regulatory Affairs Specialist
4 weeks ago
QUALIFICATIONS Bachelor of Science degree in Biology, Chemistry, Pharmacology, Toxicology, or related Health Sciences. Preference given to 5 or more years’ experience with Health Canada, Medical Devices Regulations, Regulatory Administration, Product Compliant Handling, SOP implementation in a Distribution Environment, GMP, Pharmaceutical, regulatory affairs, product submission and/or product market release.
CORE COMPETENCIES Excellent verbal and written expertise and strong interpersonal and collaborative abilities to engage with individuals at all levels, across the organization both internally and externally. Strong understanding of GMP, Food and Drug Act, Medical Device Regulations, Natural Health Products regulation. Strong project management skills, technical aptitude, and the ability to see the bigger picture. Good understanding of Quality systems in a Good Manufacturing Practices (GMP) environment. Strong problem-solving and decision-making skills in a team environment. Collaborates well with others. Strong commitment to quality, exceptional attention to detail, meticulous by nature. Strong organization, able to work independently, prioritize deadliness, and must be able to multi-task and manage and meet timelines. Ability to exercise initiative, sound judgement and decision making within the scope of authority. Fosters an inclusive and respectful work environment for all.
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