Jobs in Kitchener, Canada

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:

1. Support the preparation, compilation, and submission of regulatory filings for different dosage forms to Health Canada (NDS, S/NDS, ANDS, S/ANDS etc.).
2. Maintain regulatory documents and submissions in compliance with company procedures and Health Canada regulations, ensuring accuracy, completeness, and timeliness.
3. 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.
4. Communicate with internal and external stakeholders to obtain documents required to support regulatory submissions, communicate the company’s position and work to eliminate hurdles.
5. Assist in the preparation of responses to regulatory queries and requests for additional information from the relevant stakeholders.
6. Review labeling, packaging, and promotional materials for regulatory compliance.
7. Track and report on the status of regulatory submissions and approvals to stakeholders.
8. Support regulatory audits and inspections by health authorities, ensuring all documentation is accurate and readily available.
9. Stay informed about changes in Canadian regulations and guidance documents relevant to pharmaceuticals/biosimilars.
10. Monitor and maintain regulatory compliance of the product through post-approval activities and filings.
11. 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.
12. Maintain regulatory status tracker/files/database.
13. Additional duties as assigned by the Regulatory head.

Skills & Qualifications:

1. Bachelor's degree in life sciences, pharmacy, chemistry or related Health Sciences, advanced degree (e.g., MSc) preferred.
2. Graduate Certificate in Pharmaceutical Regulatory Affairs.
3. Must have a minimum of 2 to 3 years of experience filing regulatory submissions with Health Canada.
4. Knowledge of CMC requirements and able to analyze and draw conclusions from scientific data.
5. Experience with eCTD software.
6. Strong interpersonal skills and ability to foster strong independent working relationships with key stakeholders (internally and externally).
7. Knowledge of Canadian Food and Drugs Act and Food and Drug Regulations, GMPs, ICH Guidelines and Health Canada Policies & Guidelines.
8. Ability to prioritize workload and effectively manage multiple projects in a fast-paced, results-oriented environment to ensure all deadlines are met.
9. Excellent organization, written and oral communication skills.
10. Strong commitment to quality, accuracy, and detail.
11. Ability to work well under pressure in a team-based environment.
12. Strong problem-solving skills and a proactive approach to tasks.

Language Requirement:

1. French if known, is an asset.

Schedule:

Monday to Friday 9 am to 5 pm EST.

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