Biolyse Pharma situated in St Catharines, Biolyse Pharma is a sterile manufacturing company that produces oncology products. Biolyse is searching for professional and talented individuals who are enthusiastic, goal oriented and focused on their future career. We looking forward to hearing from you soon.

Key Responsibilities:

- Regulatory Submissions & Compliance:
- Prepare, compile, and submit electronic Common Technical Document (eCTD) dossiers for various regulatory filings.
- Submit variations, amendments, and renewals for existing drug products.
- Liaison with Regulatory Agencies:
- Communicate with regulatory authorities regarding product approvals, inspections, and compliance updates.
- Respond to regulatory inquiries and deficiency letters.
- Documentation & Record Management:
- Maintain regulatory databases and document repositories for all submissions, approvals, and correspondences.
- Ensure regulatory filings are complete, accurate, and submitted within deadlines.
- Cross-functional Collaboration:
- Work with R&D;, Quality Assurance (QA), Quality Control (QC), Manufacturing, and Clinical teams to align regulatory requirements with company objectives.
- Support regulatory compliance for labeling, packaging, and marketing materials.
- International Client Communication & Documentation Support:




- Act as the primary point of contact for international clients regarding regulatory requirements and compliance.
- Provide requested regulatory documents, certificates, and supporting materials for global partners and clients.
- Ensure that all regulatory documentation provided to clients aligns with the requirements of their respective regulatory agencies.

Preferred Qualifications:

- Education: Regulatory Affairs Diploma / Scientific degree
- Experience: 1–5 years of experience in pharmaceutical regulatory affairs.
- Technical Skills:
- Knowledge of ICH guidelines, FDA/Health Canada/EMA regulations, and Common Technical Document (CTD) formats.
- Proficiency in regulatory submission software (e.g., eCTD tools).
- Soft Skills:
- Robust attention to detail, analytical skills, and ability to interpret complex regulations.
- Excellent written and verbal communication skills.

Job Types: Full-time, Permanent Pay: $19.00-$21.00 per hour

Ability to commute/relocate

- St. Catharines, ON L2S 3Y2: reliably commute or plan to relocate before starting work (preferred)

Experience:
- regulatory Affairs: 1 year (preferred)

Location:
- St. Catharines, ON L2S 3Y2 (preferred)

Work Location: In person

📌 Regulatory Affairs Specialist (St. Catharines)
🏢 Biolyse Pharma
📍 St. Catharines