Regulatory Affairs Specialist
3 weeks ago
Vitalus Nutrition has grown from a small family-owned business to a trusted international supplier of specialty dairy ingredients for large-scale processors and brands. Our transparent, ethical and service-driven approach has helped us build long-standing relationships with customers throughout the world. Our purpose is to improve lives by unlocking the nutritional value of milk.
**Bringing Milk to Life**
We constantly look for ways to improve the work environment, provide a safe workplace, communicate company information, encourage employee collaboration, and provide ongoing training to assist employees in performing their current job and preparing for career opportunities. Our compensation and benefits package is very competitive.
We pride ourselves on creating a healthy, respectful, and safe work environment where managers and co-workers care about who you are and support you in learning this new role. As a company, our employee engagement is higher, this relates to our core values of CARE, INTEGRITY and EXPERTISE.
**POSITION OVERVIEW**:
The **Regulatory Affairs Specialist** additionally is responsible for providing strategic regulatory guidance and delivering global regulatory strategy for product development, manufacturing and registration and reviewing published information and promotional/advertising materials for regulatory compliance.
- *
VALUES: Integrity, Care & Expertise (ICE)*
- **PURPOSE: Improving Lives - By unlocking the Nutritional Value of Milk**
**KEY RESPONSIBILITY AREAS**
- Prepare, submit, and coordinate regulatory submissions and dossiers within a global environment.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Negotiate directly with Health Canada, US FDA and other external regulatory authorities to resolve any regulatory issues.
- Conduct regulatory reviews on the acceptability and regulatory status of new products, ingredients, and processes.
- Maintain registration compliance for approved products to support the ongoing marketing in Canada, the US and foreign markets.
- Updates and manages all domestic/international technical product information within the internal database and provides documentation, as needed.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
**COMPETENCIES (Knowledge, Skills, Ability)**
- Solid understanding of product development including pharmacology, toxicology, and clinical studies
- Knowledge and experience in nutritional science, product formulations (raw materials through finished products) and advertising standards in a scientific and regulatory context.
- Working knowledge of International Food Labelling regulations to support regulatory review and compliance process.
**MINIMUM QUALIFICATIONS**
- University degree in a related scientific discipline.
- 3-5 years’ experience in regulatory affairs within the Canadian food, biotechnology, or pharmaceutical industry.
- Sound knowledge of Regulatory Requirements, Operating Procedures (SOPs), Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
- Strong working knowledge of provincial and federal regulatory guidelines I.E. Health Canada, FDA, ICH.
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