About Qeen Biotechnologies

Qeen Biotechnologies manufactures GMP-grade bacteriophages and phage cocktails for therapeutic use. We are a small, fast-growing team building a manufacturing and quality platform from the ground up, which means the work here is hands-on, varied, and visible.

Job Summary

Qeen Biotechnologies is seeking a detail-oriented and highly organized Regulatory Filings Specialist to support our growing needs. This role is responsible for preparing, coordinating, and maintaining regulatory submissions and documentation to ensure compliance with applicable regulatory requirements. The successful candidate will work closely with cross-functional teams including Research & Development, Quality, Clinical, and Executive Leadership to support product development and regulatory approval activities.

As a member of a small, dynamic organization, the Regulatory Filings Specialist will also contribute to process improvements and be comfortable wearing multiple hats while helping build scalable regulatory systems.

What You'll Do:

Key Responsibilities

- Prepare, compile, review, and submit regulatory filings to applicable health authorities (e.g., Health Canada, FDA, EMA, or other international regulatory agencies, as applicable).
- Coordinate regulatory submission timelines and ensure filings are complete, accurate, and submitted within required deadlines.
- Maintain regulatory documentation, submission records, and regulatory databases.
- Support preparation of Investigational New Drug (IND), Clinical Trial Application (CTA), Device, or other regulatory submissions as appropriate to the company’s products.
- Monitor changes to regulatory requirements and communicate potential impacts to internal stakeholders.
- Collaborate with Quality Assurance to ensure regulatory documentation aligns with quality management system requirements.
- Assist in responding to regulatory agency requests, deficiency letters,



and requests for additional information.
- Support maintenance of product registrations, licenses, and renewals.
- Participate in regulatory strategy discussions and provide regulatory input during product development.
- Develop and maintain Standard Operating Procedures (SOPs) related to regulatory activities.
- Support internal and external audits as needed.
- Assist with regulatory aspects of partner, investor, and due diligence requests.

Qualifications & Skills:

- Education: Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, Microbiology, or related scientific field.
- Experience: 2–5 years of experience in regulatory affairs or regulatory submissions within biotechnology, pharmaceuticals, medical devices, or a related industry.
- Working knowledge of Health Canada, FDA, and/or international regulatory requirements.
- Excellent written, organizational, and document management skills.
- Strong attention to detail and ability to manage multiple priorities.
- Proficiency with Microsoft Office and document management systems.

You're the kind of person who:

- Pays exceptional attention to detail
- Stays organized and manages projects effectively
- Communicates clearly, both verbally and in writing
- Works independently with minimal supervision
- Collaborates well with others and contributes to the team
- Adapts quickly and is comfortable in a fast-paced startup environment
- Approaches challenges with a problem-solving mindset and looks for ways to continuously improve

Working conditions:

- Schedule: Full-time, Monday-Friday
- Work Environment: In office office setting

Benefits:

- Competitive salary.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan, and professional development opportunities

*This position is open to Canadian Citizens or Permanent residents only

Pay: $48,000.00-$55,000.00 per year

Benefits

- Casual dress
- On-site parking
- RRSP match

Work Location: In person

📌 Regulatory Filings Specialist (Gatineau)
🏢 Qeen Biotechnologies
📍 Gatineau