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.
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.
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.
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.
- Our contractors create and maintain lasting industry relationships that can be leveraged throughout their career.
- We prioritize employee needs in order to build strong partnerships that support our employees’ long-term professional success and development.
Any questions remaining?
Your consultant, Cristiano Forezli is happy to clarify anything about this vacancy. When reaching out, use the pub number: PUB406502