Qeen Biotechnologies is a global Center of Excellence for the biomanufacturing of nontraditional therapeutics. We provide services for the development and production of GMP and non-GMP bacteriophages and related delivery systems for the life sciences, pharmaceutical, agricultural, and veterinary industries.

Position Summary

We are seeking a detail-oriented and highly organized Regulatory Filings Specialist to support our growing biotech startup. 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.

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.

QualificationsRequired

• Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related scientific discipline.
• 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.

Preferred

• Regulatory Affairs Certification (RAC) or equivalent.
• Experience with electronic submission systems (eCTD or similar).
• Experience working in an early-stage or startup biotechnology environment.
• Familiarity with Quality Management Systems (QMS) and Good Documentation Practices (GDP).

Key Competencies

• Exceptional attention to detail
• Strong organizational and project management skills
• Effective written and verbal communication
• Ability to work independently with minimal supervision
• Collaborative team player
• Adaptability and comfort in a fast-paced startup environment
• Problem-solving mindset with a focus on continuous improvement What We Offer
• Opportunity to make a meaningful impact in an innovative biotech startup.
• Exposure to all stages of product development and regulatory strategy.
• Collaborative, mission-driven team environment.
• Professional growth and opportunities to expand responsibilities as the company grows.
• Competitive compensation and benefits package.