Regulatory affairs Jobs in Fergus, ON

Regulatory Affairs Associate - Permanent Full Time (Remote)

Nora Pharma is a Canadian pharmaceutical company specializing in the distribution of generic drugs across the country. The company offers a range of generic products and related services to ensure customer satisfaction.

Position Overview :

We are seeking a motivated and experienced Regulatory Affairs Associate to join our regulatory team and support regulatory activities related to Health Canada. This is an excellent opportunity for someone looking to advance their career in regulatory affairs within a dynamic and growing organization.

Responsibilities :

• Support the preparation, compilation, and submission of regulatory filings for different dosage forms to Health Canada (NDS, S / NDS, ANDS, S / ANDS etc.).
• Maintain regulatory documents and submissions in compliance with company procedures and Health Canada regulations, ensuring accuracy, completeness, and timeliness.
• Review various submission-related documents, including Batch records, Process validation Reports, Stability protocols and reports, Specifications and Testing procedures, Analytical Validation Reports, Pharmaceutical development reports, ensuring accuracy and completeness.
• Communicate with internal and external stakeholders obtain documents required to support regulatory submissions, communicate the company’s position and work to eliminate hurdles.
• Assist in the preparation of responses to regulatory queries and requests for additional information from the relevant stakeholders.
• Review labeling, packaging, and promotional materials for regulatory compliance.
• Track and report on the status of regulatory submissions and approvals to stakeholders.
• Support regulatory audits and inspections by health authorities, ensuring all documentation is accurate and readily available.
• Stay informed about changes in Canadian regulations and guidance documents relevant to pharmaceuticals / biosimilars.
• Monitor and maintain regulatory compliance of the product through post-approval activities and filings.
• Utilize eCTD software to prepare, manage, and submit electronic regulatory submissions to Health Canada. Ensure eCTD submission standards and requirements are met for successful filings.
• Maintain regulatory status tracker / files / database.
• Additional duties as assigned by the Regulatory head.

Skills & Qualifications :

Benefits :

Insurance after 3 months

Language Requirement :

Schedule :

Monday to Friday 9 am to 5 pm EST.

Location : Canada, remote. Must be able to work Eastern Hours.