Regulatory Affairs Specialist

Overview

At Saje Natural Wellness, we're nature's original farmacy, blending the superpower of plants so you can remedy real life, naturally. And like nature, we're continually growing! As we continue to build our team, we're seeking talented people to join us: in our stores, support offices, and distribution centres. We are a purpose-driven, people-first organization where collaboration, innovation and entrepreneurial mindsets thrive.

We look for individuals who have drive and warmth, agility and passion, and keep customer experience at the centre of everything they do.

At Saje, you’ll connect with a dynamic community and make a positive impact. Join our team and grow your career, alongside the most talented, hard working, and kind-hearted people out there.

The Regulatory Affairs Specialist is responsible for leading, executing, and project managing regulatory activities throughout the product lifecycle (development, licensure, launch, post-market maintenance) of an extensive product portfolio, which may include:
Natural Health Products (CA)/Dietary Supplements (US), OTC Non-Prescription Drugs (US), Cosmetics (CA/US), Consumer Products (CA/US) - hard and soft goods, and medical devices.

All Saje Team Members are responsible for contributing to Saje’s culture and maintaining a positive environment for themselves and their peers.

• Research relevant regulations, submission requirements, and options to assess new product concepts for market viability during the development stage, translating or presenting technical guidance and identifying potential obstacles to propose creative solutions through the lifecycle while keeping abreast of regulatory changes impacting product compliance. Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways.
• Responsible for regulatory documentation and submissions related to pre-market authorizations, product licensure, post-market notifications, and product vigilance programs for NHPs/Dietary Supplements, Cosmetics, General Consumer Products, Medical Devices, and/or OTCs, maintaining positive relationships with Regulatory Authorities.
• Perform due diligence and assess post-market product changes to determine impacts to market authorization. Develop and execute plan with cross-functional partners (Managers, Quality, R&D, etc.) to manage any business impacts. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
• Develop and execute regulatory strategy by conducting preliminary policy and literature searches, reviewing and compiling materials to support various types of regulatory submissions involving product formulations, specifications, evidence dossiers, or guidance documents from Regulatory Authorities.
• Identify, compare and interpret relevant Acts, Regulations, and associated Guidance (eg. Canadian F&D Act, US FD&C Act, CPSA, CPLA, Textiles Labeling Act, etc.), applying them towards business activities (e.g. concept evaluations, product copy, the Product Master Guidelines, finished product labels, promotional and advertising materials), ensuring accuracy and compliance with applicable Canadian and US regulations and/or marketing authorization of that product to minimize risk and impact to the business.
• Record maintenance to support and maintain the creation of both team and cross-functional SOP's, submission templates, files, controlled documentation, regulatory product and ingredient databases, and technical resources related to legislation, regulations, and guidelines to support the Saje portfolio of products.
• Product vigilance. Perform product deficiency-risk assessments and post-market filing of consumer incident reports to government agencies, recalls, and maintenance of other compliance reports or logs, communicating management/mitigation strategies to cross-functional team members.
• Mentor new Regulatory Affairs team members and/or contractors in following SOP's and best practices involving the review of label, website, product and marketing assets, to ensure consistency in regulatory guidance to the cross-functional teams.
• Act as project lead and a Regulatory subject matter expert in cross-functional meetings, change control plans, SOP development, and delivery of positive, timely, and productive regulatory support and education to other Saje teams. Collaborates with cross-functional teams to strategically address deficiencies in accordance with timelines dictated by Health Canada while organizing project assignments and maintaining project schedules in accordance to business plans.

• 5+ years of Regulatory and/or combined with Quality experience in at least 2 product industries: cosmetic, food, consumer good, NHP/dietary supplements, medical device (class I/II), or pharma.
• Advanced experience interpreting national, provincial, and/or local/municipal legislation, regulations, guidelines and…