Regulatory Affairs Manager (12-Month Contract) - $80,000 - $95,000 A Year (Toronto)

Regulatory Affairs Manager (12-Month Contract) - $80,000 - $95,000 A Year (Toronto)

27 Sep
|
Saje Natural Wellness
|
Toronto

27 Sep

Saje Natural Wellness

Toronto

OverviewAt 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 impact you'll makeReporting to the Director of Regulatory Affairs, the Regulatory Affairs Manager has responsibility for managing Regulatory Affairs team members, the Support team, overseeing both day to day regulatory, as well as overseeing the execution of 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.What you'll doIdentify regulatory issuesearly 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 issuesrelated 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 processesand 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 regulationson 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 stakeholderson regulatory issues, risk mitigating corrective actions,



and/or proposing measured risk-based decisions for Leadership & Executive approval.Provide training and strategic regulatory guidanceto 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 qualified associations, industry trade groups, and negotiate regulatory/industry positions as needed.Notify, consult, or brieflegal counselwith Director of Regulatory Affairs.Manage product vigilance systems and processesrelated to case/incident and annual product safety/vigilance reporting to regulatory agencies and communication of gaps/needs to internal stakeholders.Recruit, manage, develop, and mentorregulatory 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, forecastsand manage 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.We'd love to hear from you if you have7+ 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 organizational awareness and adherence to regulatory standards.Strategic thinker with strong problem-solving and decision-making capabilities.Ability to manage multiple priorities in a fast-paced environment while maintaining compliance and quality standards.Why Saje?Here at Saje, we understand that joining a team is an important decision to make, so we want to be sure you're supported to do your best work.The compensation range on average for this position is from$80,000-95,000annually. Base pay is dependent on market location and may vary depending on job-related knowledge, skills, experience, and internal equity.In addition to your base, we offer:Annual bonus programA hybrid way of workingFlexible work hours based on business needsWellness days to ensure you're taking care of your mental and physical healthHealth benefits - comprehensive health, vision and dental packagesPaid sick daysGenerous product discountFull onboarding plan and onboarding buddy to help you settle inEmployee Assistance Program - 24/7 support, resources, and information available to you and your familyPaid time off to ensure you're resting & rechargingProduct training to help you learn about the benefits and efficacy of our 100% natural products to support your own wellness journeyNote: The incentive programs, benefits, and perks have certain eligibility requirements. The company reserves the right to alter these incentive programs, benefits, and perks in whole or in part at any time without advance notice.Join our team!If this opportunity sounds like you, please apply in the link below. Not sure you're 100% the right fit? We encourage you to apply even if you don't have all of the listed qualifications. We offer a thorough onboarding experience to set you up for success, learning and development support, and help you to integrate seamlessly.Saje provides equal employment opportunity to all employees and applicants, and we believe the best teams are made up of diverse perspectives and people. We offer reasonable accommodations to candidates with disabilities throughout the recruitment process and will work with you to ensure you are supported while working at Saje.#J-18808-Ljbffr

📌 Regulatory Affairs Manager (12-Month Contract) - $80,000 - $95,000 A Year (Toronto)
🏢 Saje Natural Wellness
📍 Toronto

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