Regulatory Affairs Specialist

7 days ago

Mississauga, Canada Juno Pharma Canada Inc. Full time

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.

**Job Type**: Permanent

**Benefits**:

- Assurance Dentaire
- Assurance Invalidité
- Assurance Vie
- Assurance Vision
- Cotisation égale au RÉER
- Événements d'Entreprise
- Programme d'Aide aux Employés
- Stationnement sur place

Schedule:

- Du Lundi au Vendredi

Work Location: In person

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