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Regulatory Affairs Specialist

10 hours ago

Vancouver, Canada Saje Natural Wellness Full time

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 impact you'll 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 Saje’s culture and maintaining a positive environment for themselves and their peers.

What you'll do:

- 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 (e.g. 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 maintains project schedules in accordance to business plans.

We'd 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 product's 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 you're supported to do your best work.

The compensation range on average for this position is from $65,000-80,000 annually. 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 program
- A hybrid way of working
- Flexible work hours based on business needs
- Wellness days to ensure you're 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 you're 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 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.

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