Regulatory Affairs Specialist

Nora Pharma is a Canadian pharmaceutical company specializing in the distribution of generic medications across the country. Nora Pharma positions itself as a partner of choice in optimizing service offerings to pharmacies and their patients. The company's mission is to innovate within the Canadian pharmaceutical ecosystem as a growth partner for pharmacists by providing patients with access to high-quality, affordable pharmaceutical products.
Under the supervision of the Regulatory Affairs Manager, the Regulatory Affairs Specialist will support the AR team in activities related to Health Canada.

We offer:

• Young and dynamic team

• Flexible and hybrid schedule

• 37.5 hours/week, temporary position (from now until September 30, 2026)

• Comprehensive group insurance

• 100% remote work possible, if located far away.

Main tasks and 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, 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.

• 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.

• Additional duties as assigned by the Regulatory head.

Requirements and skills

• Bachelor's degree in life sciences, pharmacy, chemistry or related Health Sciences, advanced degree (e.g., MSc) preferred.

• Graduate Certificate in Pharmaceutical Regulatory Affairs.

• Must have ideally 1 to 3 years of experience filing regulatory submissions with Health Canada.

• Knowledge of CMC and labeling requirements and able to analyze and draw conclusion from scientific data.

• Experience with eCTD software.

• Strong interpersonal skills and ability to foster strong independent working relationships with key stakeholders (internally and externally).

• Ability to prioritize workload and effectively manage multiple projects in a fast-paced, results oriented environment to ensure all deadlines are met.

• Excellent organization, written and oral communication skills.

• Strong commitment to quality, accuracy and detail.

• Ability to work well under pressure in a team-based environment.

• Strong problem-solving skills and a proactive approach to tasks.

• Intermediate/advanced spoken and written English required (relationship with English-speaking partners)

• Knowledge of French is an asset.

Job Type: Temporary, Full-time
Salary : between $35 and $38/hour, depending on education and experience

Benefits:

• Dental Insurance
• Disability Insurance
• Extended Health Care
• Life Insurance
• Vision Care
• Vacation and Compensatory Time Off
• Flexible Hours
• On-site Parking
• Work from Home
  Work Days:
• Monday to Friday
• Weekends off
  Shifts:
• Remote Day shift