We are hiring for a client of ours that is a well-established producer of natural health and specialty food dietary supplement products, headquartered in Prince Edward Island, Canada. As proven industry leaders, they are renowned for their cutting-edge, globally patented technologies used in manufacturing gummies and honey lozenges for the dietary supplement, natural health, and specialty food industries.
As pioneers in continuous innovation, they have access to an extensive product pipeline and possess expert in-house research and development capabilities.
As the Quality and Regulatory Specialist, your crucial role will involve upholding our Food Safety Management Systems and maintaining high-quality standards. You will also be responsible for handling our regulatory requirements.
KEY RESPONSIBILITIES
- Provide regulatory expertise to support both domestic and international sales.
- Develop and execute regulatory strategies for Natural Health Products (NHP) to achieve our business objectives.
- Evaluate regulatory submissions and provide valuable feedback for improvement.
- Oversee all regulatory aspects throughout the product lifecycle, from development to post-marketing, ensuring compliance with government regulations for labels and promotional materials.
- Foster collaborative relationships with Canadian and Foreign Regulatory bodies, engaging in submission strategies, regulatory pathway development, submissions status updates, and special access processes.
- Assist and support during audits conducted by Health Canada, FDA, ANSI-455, and SQF.
- Participate and contribute to pilot scale-ups, validations, and stability assessments by establishing process parameters for new products.
- Define and agree on the manufacturing process, assess critical parameters, and provide technical input as necessary.
- Assist in maintaining the change control process of Quality System Records to ensure compliance with Good Manufacturing Practices (GMP).
- Handle customer complaints, conduct investigations, and track them in the internal database, ensuring appropriate follow-up.
- Participate in deviation and incident reporting and internal complaint investigations to maintain compliance.
- Lead and participate in the review of the Annual Product Quality Program.
- Update and maintain Quality Specifications for raw/packaging materials, in-process, and finished products.
- Review and participate in the maintenance of Standard Operating Procedures (SOPs) and electronic and hard copy GMP records, FSQ Manual, Deviations, and NCR's in accordance with company policies and practices.
- Oversee the raw material and finished goods testing program.
- Support operations by conducting necessary Quality checks on the plant floor.
- Provide or facilitate training for operators and managers on quality systems and related issues.
- Collaborate on the Company's Continuous Improvement initiatives.
- Perform any other duties as required.
QUALIFICATIONS
- Hold a BSc in Chemistry, Pharmacy, or another Life Science from a Canadian University or a degree recognized as equivalent by a Canadian university or Canadian accreditation body.
- Preferably, have a minimum of 5 years of experience in a quality or regulatory role within the pharmaceutical industry.
- Preferably, possess at least 3 years of experience in releasing drug/NHP products to the Canadian Market.
- 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.
- Ability to work well under pressure within a team-based environment.
- Meticulous, detail-oriented, and committed work ethic.
- Proficient problem-solving and decision-making abilities.
- Able to work independently with confidence.
- Proficient user of Microsoft Office products.
OTHER
- Must have proof of eligibility to work in Canada.
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.
Job Type: Full-time
Salary: $75,000.00-$110,000.00 per year
Schedule:
Ability to commute/relocate:
- Charlottetown, PE C1E 0K4: reliably commute or plan to relocate before starting work (required)
Experience:
- NHP/Pharmaceutical: 3 years (preferred)
- submission strategies developing: 3 years (preferred)
- communication and submissions Canadian Health Authorities: 3 years (preferred)
- communication and submissions US Health Authorities: 3 years (preferred)
Work Location: In person
