Regulatory Affairs Manager

Overview

At Saje Natural Wellness, we're nature's original farmacy, blending the superpower of plants so you can remedy real life, naturally. 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, hardworking, and kind-hearted people out there.

The impact you ll make: Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Manager has responsibility for managing Regulatory Affairs team members and the Support team, overseeing day-to-day regulatory work, and executing complex regulatory strategies during the product lifecycle that may impact product compliance of NHPs/Dietary Supplements, Cosmetics, General Consumer Products, Medical Devices, and/or OTCs. All Saje Team Members are responsible for contributing to Saje’s culture and maintaining a positive environment for themselves and their peers.

• Identify regulatory issues early in the product concept stage, submissions process, or documentation acquisition that could impact product launch. Negotiate with regulatory authorities and stakeholders, conducting technical meetings as needed to ensure submission approval.
• Oversee new or complex regulatory issues 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 to relevant authorities.
• Manage and develop internal review processes and provide input to product lifecycle planning as they relate to key regulatory strategies, deliverables, history of precedence, or regulatory climate.
• Identify & monitor impact of changing regulations on submission strategies or market authorizations, applying risk-benefit techniques to anticipate regulatory obstacles and developing solutions with the Regulatory and associated teams.
• Problem-solve and advise internal stakeholders on regulatory issues, risk mitigating corrective actions, and/or proposing measured risk-based decisions for Leadership & Executive approval.
• Provide training and strategic regulatory guidance to ensure company-wide compliance status or risk-awareness across product market positioning, operational activities, and quality compliance risks are communicated to leadership.
• Regulatory/policy advocacy. Develop international regulatory agency partnerships to explore new pathways and market products across different regulatory jurisdictions. Participate and/or represent in professional associations, industry trade groups, and negotiate regulatory/industry positions as needed.
• Notify, consult, or brief legal counsel with Director of Regulatory Affairs.
• Manage product vigilance systems and processes related to case/incident and annual product safety/vigilance reporting to regulatory agencies and communication of gaps/needs to internal stakeholders.
• Recruit, manage, develop, and mentor regulatory team on key team deliverables: compliance of packaging, promotional/marketing/advertising materials, product submissions, and post-market product vigilance programs.
• Acquire, oversee, and manage Regulatory Affairs Support/consultants, including the negotiation of agreements, project expectations, responsibilities, briefings, issue task orders, and manage day to day workflow traffic control.
• Manage Regulatory team budgets, forecasts, and expenditures to ensure the team is within financial wellness.
• Develop and maintain a positive and productive, educational and supportive relationship with cross functional team members and external contacts.

• 7+ years of progressive experience in Regulatory Affairs, including managing regulatory strategies and submissions, with some leadership experience.
• Proven experience with pre-market authorizations, product licensure, and post-market compliance for NHPs/Dietary Supplements, Cosmetics, Medical Devices, OTCs, and/or General Consumer Products across multiple jurisdictions.
• Deep understanding of global regulatory frameworks, policies, and compliance requirements.
• Demonstrated ability to interpret and apply changing regulations, assess risk-benefit scenarios, and develop proactive strategies.
• Skilled in regulatory negotiations with authorities and industry associations; experience in advocacy and policy development is an asset.
• Strong knowledge of product vigilance systems, safety reporting, and lifecycle management.
• Proven ability to lead and mentor regulatory teams, manage consultants, and oversee budgets and forecasts.
• Exceptional stakeholder management and communication skills, including the ability to brief executives and collaborate cross-functionally.
• Experience delivering training and compliance programs to ensure…