Regulatory and Quality Specialist
Vacancy number • PUB406502
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
- 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.
- 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.
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.
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.
Empowering people is our business. Our specialist recruiters strive to connect talented individuals with opportunities that align not only with your immediate expectations, but your long-term career trajectory as well. Brunel has built a reputation for working with some of the world’s largest and most innovative businesses. Talk to us about how we can help you to reach your goals.
Brunel connects the most talented and experienced specialists with both present-day and pioneering projects. With 120+ offices and more than 12,000 specialists around the world, we deliver people and workforce services that transform global projects in Mining, Oil & Gas, Renewable Energy, Infrastructure and Life Sciences.
Brunel is passionate about ensuring we are a business with a conscience. Not only does Brunel have a defined global Environmental, Social and Governance (ESG) strategy, but we also have our own dedicated Brunel Foundation which has been working to ensure that we are contributing to a better future for both our people and planet for over 10 years.
Do you have questions?
If you have questions or would like to discuss the details of this role, please contact Cristiano Forezli quoting publication number: PUB406502