Senior Regulatory Affairs Specialist

Join Our Team at Bio Agri Mix LP – Now Hiring Senior Regulatory Affairs Specialist
Mitchell, Ontario Perth County is near Stratford (20 minutes), centrally located between London and Kitchener (45 minutes)

About Us:
Bio Agri Mix LP is a leading Canadian manufacturer of animal feed medicants and animal health care products with over 40+ years of success. As a Health Canada licensed, FDA-approved, and HACCP-certified company, we proudly serve the Canadian market with a strong commitment to safety, quality, and innovation.

Description:
We are seeking an experienced Regulatory Affairs professional to serve as the Senior Regulatory Affairs Specialist. This new role contributes to product development, regulatory submissions, and regulatory compliance. The Senior Regulatory Affairs Specialist reports to the Director of Regulatory Affairs & Compliance.

Compensation & Benefits:

- Minimum starting Salary Rate: $70,000 per annum. Salary will be commensurate with knowledge and related experience.
- Health Benefits: Eligible after a successful 90-day probation period
- Group RSP Plan: Eligible after a successful 90-day probation period
- Holiday Bonus: $1,000 (pro-rated based on start date and active days worked)

Work Schedule:

- Day Shift: Monday to Thursday | 8:00 AM – 4:30 PM | and Friday 8:00 AM – 4 PM

Key Responsibilities:

- Conduct regulatory assessments and gap analyses for new products
- Prepare product development plans for new products
- Prepare for and participate in pre-submission meetings with regulatory authorities in target jurisdictions (e.g.,



Veterinary Drugs Directorate in Canada, the Center for Veterinary Medicine in the US)
- Review study protocols, amendments, deviations, and notes to file prepared by RA Specialists for trials
- Review regulatory submissions for Canada and other jurisdictions
- Address deficiency letters and clarification requests issued by regulatory authorities to achieve product approvals
- Review laboratory and production data for accuracy and compliance with regulatory standards
- Conduct regulatory assessments for change controls
- Maintain relationships with external regulatory consultants and contractors
- Schedule and lead the weekly R&D; meetings

Qualifications:

- Bachelor’s degree or Master’s degree in biological sciences, animal sciences, pharmaceutical sciences, chemistry, or related field.
- Minimum 5 years of experience working in regulatory affairs within the Canadian animal health industry.
- Extensive knowledge of the Food and Drugs Act and Regulations as they pertain to veterinary drugs

Skills Required:

- High attention to detail and organizational skills
- Ability to maintain a solid focus on assigned tasks
- Ability to work efficiently and meet deadlines
- Ability to multitask and prioritize
- Ability to work collaboratively in a team environment




- Display a positive attitude and willingness to take on new tasks
- Lend support to colleagues in other departments
- Clear and effective oral and written communication

Why Join Bio Agri Mix LP?

- Long-standing, reputable company in a growing industry
- Opportunities to develop a stable, long-term career in pharmaceutical manufacturing
- Inclusive, accessible workplace that supports employee growth and well-being

Application Instructions:

If you are interested in a career with a reliable employer in the animal health industry and meet the requirements, we encourage you to submit your resume for consideration.

Please apply only if you:

- Applicants must be legally entitled to work in Canada (e.g., Canadian citizen, permanent resident, or valid work permit).

Apply through the Indeed portal or by Email: [email protected]

or
Drop-off: 11 Ellens Street, Mitchell, ON

We thank all applicants for their interest; however, only those selected for an interview will be contacted.

Accessibility Statement:
Bio Agri Mix LP is an equal opportunity employer. We are committed to an inclusive, accessible workplace. Accommodations are available upon request for candidates during all stages of the recruitment process. Please contact Human Resources to make arrangements.

Recruitment Process:
All applications are reviewed by our Human Resources team. We do not rely on automated decision-making tools to screen or select candidates. Hiring decisions are made by qualified personnel based on job-related criteria.

📌 Senior Regulatory Affairs Specialist (Mitchell)
🏢 BIO AGRI MIX
📍 Mitchell