Regulatory Affairs Specialist

1. JOB OBJECTIVES

• Prepare documentation for submission to regulatory authorities to obtain market approval for new products, as well as approval for proposed changes to existing products during the post-marketing phase.
• Participate in the post-marketing follow-up program to ensure product compliance and provide support to clients.
• Establish a regulatory strategy.

2. PRIMARY FUNCTIONS

Regulatory Affairs

• Prepare regulatory submission documentation for the relevant authorities.
• Follow up on files with regulatory agencies until new products are approved.
• Monitoring regulatory strategies for new product development and post-marketing project changes.
• Ensure the quality of documents to be submitted.
• Stay up to date on changes and updates to regulations in different countries.

Other

• Ensure deadlines are met and advise supervisor of any changes.
• Ensure compliance with workplace health and safety norms.
• Carry out any other related tasks deemed relevant to this position

3. EXPERIENCE REQUIREMENT AND APTITUDES

• Bachelor’s degree in science or pharmacy or DESS in drug development.
• 10 years of experience in a similar position in the pharmaceutical industry.
• Good knowledge of Canadian and US regulations and Canadian and other Good Manufacturing Practices (GMP).
• Knowledge of chemistry.
• Bilingualism (French/English) and excellent written and oral communication skills.
• Knowledge of computer tools, in particular the Microsoft suite (Word, Excel, Powerpoint).
• Ability to complete several projects simultaneously
• Attention to detail and good writing skills
• Ability to summarize and organize.
• Good learning skills.
• Team spirit and interpersonal skills.
• Ability to manage priorities and work under pressure with tight deadlines and/or frequent changes of priority.