Regulatory Affairs Manager

Overview:

Our client, a Producer of Medical Cannabis products licensed under Health Canada’s ACMPR and Bill C45, is in need of an experienced Regulatory Affairs Manager to oversee all regulatory tasks in Canada, the US and Europe specifically as it relates to registration and compliance for cannabis and related products including but not limited to Natural Health Products, Nutraceuticals, Health, Wellness, and Beauty Products, and OTC and DIN products. The Regulatory Affairs Manager will play a key role in the support of regulatory activities to obtain and maintain product registration status in compliance with Canadian, US, European, (and other jurisdictions') laws and regulations. This is a full time permanent role with opportunities for rapid career growth.

Responsibilities:

Reporting to the Director, Quality Assurance (QA), RA Manager:

• Prepares and compiles regulatory submissions to Health Canada.
• Works in full compliance with laws & regulations, business rules, and standards of Business Conduct and Ethics.
• In conjunction with the Director, liaises with Health Canada.
• In collaboration with the Director, reviews/assesses and responds to HC requests and decisions.
• Develops and implements regulatory strategies
• Works with internal teams (e.g. Packaging, Marketing, QA, etc.) to provide accurate and timely responses to Health Canada.
• Provides regulatory guidance to internal teams on messaging, promotional material review
• Collaborates with internal stakeholders to ensure alignment of regulatory affairs strategy with business priorities.
• Monitors the regulatory environment, interpret changes, analyze gaps and support or conduct impact assessment, and participate/lead in the implementation of changes
• Leads the Regulatory Affairs efforts globally.

Qualifications:

• 5+ years experience in a Regulatory Affairs role within pharmaceutical, cosmetics, or other relevant fields.
• Specialized education and/or training in Regulatory Affairs
• Familiarity with Canadian and ideally other regulatory environments and institutions