Regulatory and Quality Specialist

Vacancy number • PUB406502

Regulatory and Quality Specialist

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

Start applying immediately

About this job

  • Market: Life Sciences & Health Care
  • 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
  • Closing date: Monday, April 1, 2024

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.

What you need to bring:

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.

Anything Else?

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.

Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.
Explore your career opportunities!

At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.

Learn more about our global network of specialists!

Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.
Join us on our mission!

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 this number: PUB406502