Regulatory Affairs Specialist

2 weeks ago

Vancouver, Canada Saje Natural Wellness Full time

**Overview**:
For over 25 years we’ve been helping our community with essential oil blends that actually work. These essential oil blends treat stress, pain, gut, balance, and support in relaxation prior to sleep, and for symptoms of coughs and colds. We know that a life committed to wellness is greater than one focused on illness, and believe that reaching for natural can enhance your long-term health and wellness, every day.

We have been ranked by Canadian Business and PROFIT as one of Canada’s fastest growing companies. To support us on our journey, we are seeking diverse, purpose-lead people to join our team.

Get ready to celebrate global wellness with us.

**Description**:
The **Regulatory Affairs Specialist** is responsible for leading and project managing regulatory activities throughout the product lifecycle to support the development, licensure and pre
- and post-market maintenance of an extensive product portfolio, which may include: Natural Health Products (CA), OTC Non-Prescription Drugs (US), Cosmetics (CA/US), Consumer Products (CA/US) - hard and soft goods,and medical devices.

Through day-to-day functions, the **Regulatory Affairs Specialist**,** contributes to maintaining and strengthening Saje’s culture; proactively engaging in behaviours that align with Saje’s values: Wellness, Growth, Celebration, Greatness and Belonging.

**Responsibilities**:

- Contributes to a team environment where all Team Members consistently experience a sense of belonging and inclusion
- Assess new product concepts for market viability during the development stage, following products through the lifecycle to market entry while keeping a pulse on regulatory changes impacting product compliance.
- Develop and execute regulatory strategy by conducting preliminary policy and literature searches, reviewing and compiling materials to support various types of regulatory and certification submissions involving product formulations, specifications, evidence dossiers, or guidance documents from Regulatory Authorities.
- Support the creation of both team and cross-functional SOP's, and maintenance of controlled documentation, regulatory databases, and technical resources.
- 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.
- Negotiate and/or interact with Regulatory Authorities, maintaining positive relationships during submission, post-licensing requests, and/or manage inquiries related to regulatory changes impacting product launch.

**Applicant Requirements**:

- Minimum Bachelor's and/or Master's degree in the Science, Health Sciences, Legal/Policy/Public Administration/Business field and/or relevant higher level education or Regulatory Certification.
- 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, mananging 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.
- Able to contribute to a team environment and facilitate the Saje experience of a culture of wellness, belonging and community.

**Key Relationships**:
Reporting to the Senior Manager of Regulatory Affairs

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