Regulatory Affairs Specialist (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:

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 Sajes culture and maintaining a positive environment for themselves and their peers.

What youll do:

• Research relevant regulations submission requirements and options to assess new product concepts for market viability during the development stage translating or presentingtechnical guidance and identifying potential obstacles to propose creative solutions through the lifecycle while keepingabreaston regulatory changes impacting a full understanding of area of specialization to resolve a wide range of issues in creative ways.
• Responsible for regulatory documentation and submissionsrelated 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 SOPs 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 SOPs 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 expertin cross-functional meetings change control plans SOP development and delivery of positive timely and productive regulatory support and education to other Saje with cross-functional teams to strategically address deficiencies in accordance with timelines dictated by Health Canada while organizingproject assignments and maintains project schedules in accordance to business plans.
  

Wed love to hear from you if you have:

• 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 policies in the product lifecycle managing the submission process and marketing compliance.
• Experience with US and/or international regulations also highly desirable.
• Understanding of GxPs clinical research operations product and policy development processes to fulfill job duties.
• Possesses the ability to review and accept quality vendor preclinical and clinical documents in support of a regulatory submission.
• Strong organizational and project management skills to manage complex regulatory issues and multiple product types.
• Ability to communicate and educate clearly on regulatory policies interdisciplinary deficiencies providing balanced evaluations for cross-functional teams in written reports and meetings.
• Strong analytical strategic thinking and problem-solving to perform due diligence risk-benefit analyses and assess a products market viability.
• Self-motivated and self-directed able to multitask prioritize and manage time efficiently staying on track to key dates and managing expectations.
• Strong knowledge of MS Office (Word Excel PowerPoint and Outlook) SharePoint and product project management systems.

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.