Regulatory And Quality Specialist

Hiring By - Biostaffic

 BioPharma

Canada

Job Highlights

Not Disclosed

Entry level

Posted 4 months ago
Job details
Regulatory and Quality Specialist Location: Charlottetown, PEI. We are hiring a Regulatory and Quality Specialist for our client, an established natural health and specialty food dietary supplement product producer who specializes in the production of gummies and honey lozenges for dietary supplements, natural health, and specialty foods. Working on-location in Charlottetown, PEI, the successful candidate will play a pivotal role in the Regulatory function, onboard new customers, and support the maintenance of our Food Safety Management Systems and Quality standards. This is a permanent opportunity available immediately. KEY RESPONSIBILITIES Provide regulatory expertise for domestic and international sales through the development and implementation of regulatory processes aligned to our business objectives. Manage all regulatory aspects of the product lifecycle from development, premarket to post-marketing phase including reviewing and approving labels and promotional material in compliance with government requirements. Lead the Quality process for onboarding new customers and ingredients. Guide product labeling and artwork projects to ensure compliance for internal brands and liaison with contract manufacturing partners to streamline the path to market. Manage submissions to various governing agencies for product licensing. Maintain knowledge of regulatory requirements for the dietary supplement category including packaging and documentation trends. Develop and maintain collaborative relationships with Canadian and Foreign Regulatory bodies to support submission strategy, regulatory pathway development, submissions status, and special access processes. Partner with Senior Quality Manager to ensure the Quality department is successful and aligned with business objectives. Participate in the review of the Annual Product Quality Program. Collaborate on any Company’s Continuous Improvement initiatives. Other duties as required. QUALIFICATIONS BSc in Chemistry, Pharmacy, or other Life Science. Recognition as equivalent by a Canadian university or Canadian accreditation body would be an asset. 5+ years in a regulatory or quality role working in the pharmaceutical industry is preferred. 3+ experience with releasing drug/NHP products to the Canadian Market is preferred. Thorough and demonstrated knowledge of ICH Guideline, FDA-CFR regulations, Health Canada, and other relevant regulations. Strong written and verbal communication skills. Excellent organization, time management, and prioritization skills Works well under pressure in a team-based environment. Meticulous and detail-oriented with a strong work ethic Sound problem-solving and decision-making abilities. Works independently with confidence. Proficient user of Microsoft Office products OTHER Must have proof of eligibility to work in Canada. PHYSICAL ASPECTS OF POSITION (INCLUDES BUT IS NOT LIMITED TO): Stand, or walk for an extended period on a hard surface. Lift to 25 lbs. Work in a variety of temperatures Working with personal protective equipment Noise

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Canada

Experience:

  • Entry level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 17, 2024
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