Kye Pharmaceuticals Inc. is a Canadian pharmaceutical company committed to bringing value to Canadians with medicines that fulfill clinically significant unmet needs. Our experienced team offers expertise in the Canadian pharmaceutical landscape from registration through to commercialization.

With a rapidly growing portfolio of in-licensed new drug products, Kye has a unique opportunity and an immediate opening for a Regulatory Affairs Manager (RAM) based in North York, ON. The successful candidate will join a team of highly motivated professionals committed to a creative and integrative working model based wholly on scientific and medical integrity. The RAM is a dynamic individual who will be responsible for coordinating all manner of regulatory submissions/reviews, as well as creating clear and concise clinical documentation, according to internal policies/practices, for the preparation of high-quality regulatory dossiers supporting Kye business priorities.

Kye believes strongly in mentoring, training, and developing our employees in an environment that values diversity. Reporting directly to the VP, Scientific Affairs, the responsibilities of the RAM are expected to grow.

Responsibilities:

• Authoring local dossiers and/or reviewing/converting global regulatory dossiers for submission to Health Canada. ensuring adherence to Health Canada's regulations, polices and the Food and Drug Act.
• Support the development of Regulatory Strategy and Risk management assessments.
• Preparation of pre-submission meeting materials and participation in meetings, as assigned
• Coordination of Health Canada reviews, preparation of responses, and interacting with partners to ensure timelines are met
• Advocate to shape and influence the regulatory policy environment to maximize and protect Kye's interests and proactively assess/communicates impact of regulatory policy change by reviewing and monitoring Health Canada initiatives.
• Identification of dossier issues and recommend actions to effectively address them prior to submission
• Review and assessment of product life cycle post approval changes and implementing required regulatory actions to ensure compliance is maintained
• Interaction with Health Canada as required and ensuring the maintenance of excellent working relationships with Health Canada and Industry Associations fostering Kye's external reputation based on integrity.
• Other duties/projects as assigned

Qualifications:

• University degree (BSc. or M.Sc. in Pharmacy, Pharmacology, Chemistry, Biological Sciences, or equivalent with a minimum of 5 years of Regulatory Industry experience.
• Regulatory Affairs Certification from an accredited college programme is preferred.
• Outstanding communication skills (written, verbal, interpersonal).
• Understanding of the pharmaceutical drug development process, guidelines, and regulations locally and, ideally, also globally (US and EU, most importantly).
• Aptitude and willingness to develop new skills
• Ability to work cross-functionally and independently
• Successful at time/project management
• Ability to work on multiple projects in a deadline driven, fast-paced environment
• English proficiency