Regulatory Affairs - Quality Control Coordinator

Overview:

Theralase® Technologies Inc. (“Theralase®”) is a publicly traded Canadian federal corporation (TSXV: TLT; OTCQB: TLTFF) focused on the destruction of cancer, bacteria and viruses consisting of two primary divisions:

1. Drug Division – Preclinical research and clinical development of energy-activated small molecules and the energy systems that activate them to safely and effectively destroy various cancers, bacteria and viruses.
2. Device Division - Manufacturer and distributer of proprietary super-pulsed Cool Laser Therapy (“CLT”) medical lasers, primarily in Canada and the United States, for the treatment of knee pain, and in off-label use, treatment of numerous nerve, muscle and joint conditions. In addition, the Device Division designs and manufactures proprietary medical laser systems used to activate the small molecules in the Drug Division.

Additional information is available at www.theralase.com and www.sedarplus.com

:

The Regulatory Affairs - Quality Control Coordinator (“RAQCC”) will work in the Drug Division and be responsible for the manufacture, quality control and regulatory submissions of pharmaceutical drugs; specifically:

1. Prepare, compile and submit regulatory dossiers to Health Canada (“HC”), the Food and Drug Administration (“FDA”), European Medicines Association (“EMA”) or other authorities; including: HC Current Drug Submissions (“NDS”), FDA New Drug Applications (“NDA”), HC Clinical Trial Applications (“CTA”), HC Investigational Testing Authorizations (“ITAs”), FDA Investigational New Drug (“IND”) applications, clinical protocols, Informed Consent Forms (“ICF”) and other regulatory submissions
2. Track deadlines and respond to queries of the respective regulatory authorities and respond accurately, succinctly and in a timely manner, according to their requests.
3. Monitor policy changes that may affect the pharmaceutical products submission and approval status
4. Maintain controlled document systems, ensure electronic Common Technical Document (“eCTD”), eCTD‑like sections are complete,



accurate and submitted to the regulatory authorities in a timely manner
5. Manage pharmaceutical product labeling compliance
6. Have an excellent working knowledge of Good Manufacturing Practices (“GMP”), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”), Good Clinical Practices (“GCP”), Good Laboratory Practices (“GLP”) and local regulations and apply consistently to all regulatory submissions
7. Verify that product claims, packaging and promotional materials meet regulatory standards prior to public release
8. Track and manage post‑approval changes, variations and renewals of the pharmaceutical products with the regulatory authorities
9. Work with Quality Control (“QC”) labs and Contract Research Organizations (“CRO”) in the manufacture of the pharmaceutical products to ensure batches meet cGMP standards before release
10. Maintain pristine quality records, Standard Operating Procedures (“SOPs”) and Quality Management System (“QMS”) documentation for the pharmaceutical products and their release
11. Review, maintain and audit quality documentation for audit-ready regulatory reviews
12. Implement and successfully close investigation into product deviations, Out‑Of‑Specification (“OOS”) results and Corrective And Preventive Action (“CAPA”) analysis and reports
13. Partner with Chemistry, Manufacturing and Controls (“CMC”), PharmacoVigilance (“PV”) and clinical teams to align quality and regulatory requirements

A full-time, in-office position at the Company’s headquarters located in midtown Toronto, easily accessible via public transit.

Qualifications:

Bachelor of Science degree in life science,



health science or pharmaceutical science

- Specialized post-graduate credentials and hands-on laboratory/compliance training on pharmaceutical drug regulatory affairs and quality compliance
- Strong working knowledge of HC and FDA regulatory submissions and procedures
- Robust technical writing and analytical interpretation skills to translate complex health legislation into operational procedures
- Broad knowledge of both regulatory and manufacturing quality systems (HC, FDA, ICH, GMP, GCP)
- Understanding of pharmaceutical drug development and manufacturing quality processes
- Ability to manage multiple deadlines and regulatory timelines
- Collaborative, cross‑departmental communication skills.
- 5+ years’ experience in a similar role
- Excellent verbal, written and interpersonal skills with the ability to interact and build positive relationships proactively with all employees and external consultants
- Proficiency in Microsoft Office (e.g.: Word, Excel, Power Point, Publisher)

Responsibilities: Compile, review and submit HC, FDA and EMA regulatory submissions

- Accurately, succinctly and in a timely manner respond to regulatory requests
- Update and maintain pristine internal regulatory and quality databases that are audit-ready
- Verify labeling accuracy and compliance prior to pharmaceutical product release
- Track regulatory timelines and milestone deliverables
- Support QC labs with documentation and quality checks

Compensation: $70,000 to $90,000 base, full-time salary, commensurate with experience

- Employee benefits and stock options (subject to board of director’s approval)

Please send your resume for review and consideration. Only candidates, who are being considered for the RAQCC position will be contacted. Pay: $70,000.00-$90,000.00 per year

Benefits

- Dental care
- Extended health care
- On-site gym
- In office parking
- Stock options
- Vision care

Education:
- Bachelor's Degree (required)

Experience:
- Regulatory affairs and quality compliance: 5 years (required)

Work Location: In person

📌 Regulatory Affairs - Quality Control Coordinator (East York)
🏢 Theralase
📍 East York