Regulatory and Quality Specialist

Vacancy number • PUB406502

Regulatory and Quality Specialist

  • Charlottetown
  • Closes April 1
  • 40 hours
  • Academic Bachelor

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About this job

  • Industry: Food Production & Manufacturing
  • Area of expertise: Food Safety and Quality Assurance
  • Location: Charlottetown

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor

Introduction

We are currently hiring a Regulatory and Quality Specialist for our client. The successful candidate will be responsible for managing all regulatory aspects of the product lifecycle from development, pre-market, and post-marketing phases including reviewing and approving labels and promotional material in compliance with government requirements. This is a full-time permanent opportunity, offering hybrid working schedule, available immediately.

About this role

Responsibilities

  • Provide regulatory expertise for domestic and international sales through the development and implementation of regulatory processes aligned with 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.
  • Provide guidance on 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.

Requirements

Requirements

  • 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 strong work ethic.
  • Sound problem solving and decision-making abilities.
  • Works independently with confidence.
  • Proficient user of Microsoft Office products.

Benefits

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.

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About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

At Brunel, we believe that safety is not just a priority, but a value that is integral to our company culture at all levels of our organization.

  • We establish measurable objectives and targets, consistently reviewing our activities, risks, legal obligations, and performance.
  • Brunel Americas is a proud member of Houston Business Roundtable, & Utah Safety Council, and a participant of ISNetworld RAVS Plus Audit.
  • Brunel consistently utilizes performance measuring and monitoring. This includes meticulous record keeping and routine inspections.

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While compensation is important, finding the right cultural fit is equally crucial. At Brunel, our longstanding cultures and values have contributed to a positive employee experience, which is why some candidates have chosen to stay with us for 30 + years.

  • Our values are at the center of everything we do –Entrepreneurship, Integrity, Results-driven, & Passion for people.
  • Brunel is committed to an inclusive workforce and we understand that Diversity, Inclusion, and Belonging are essential for a successful working culture, business, and community. Thus, Brunel takes both a global and regional approach to DE&I.

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At Brunel, we prioritize candidate’s career abilities and needs even before the hiring process begins.

  • With open lines of communication and a dedicated team assigned to every contractor, we strive to make every employee experience with us as easy and seamless as possible.
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Start applying immediately

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Any questions remaining?

Your consultant, Cristiano Forezli is happy to clarify anything about this vacancy. When reaching out, use the pub number: PUB406502