Regulatory Affairs Manager (12-month Contract)

Overview:

At Saje Natural Wellness were natures original farmacy blending the superpower of plants so you can remedy real life naturally. And like nature were continually growing! As we continue to build our team were 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 youll 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 youll make:

Reporting to the Director of Regulatory Affairs the Regulatory Affairs Managerhas 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 Sajes culture and maintaining a positive environment for themselves and their peers.

What youll do:

• 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 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.
  

Wed love to hear from you if you have:

• 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 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 youre supported to do your best work.

The compensation range on average for this position is from $ annually. Base pay is dependent on market location and mayvary depending on job-related knowledge skills experience and internal equity.

In addition to your base we offer:

• Annual bonus program
• A hybrid way of working
• Flexible work hours based on business needs
• Wellness days to ensure youre taking care of your mental and physical health
• Health benefits - comprehensive health vision and dental packages
• Paid sick days
• Generous product discount
• Full onboarding plan and onboarding buddy to help you settle in
• Employee Assistance Program - 24/7 support resources and information available to you and your family
• Paid time off to ensure youre resting & recharging
• Product training to help you learn about the benefits and efficacy of our 100% natural products to support your own wellness journey

Note: 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 youre 100% the right fit We encourage you to apply even if you dont 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.