About this role
- Manages the preparation of high quality regulatory submissions, including evaluation of data, regulatory strategy and project coordination according to predefined timelines.
- Assumes responsibility for the maintenance and regulatory compliance for approved products for prescription and OTC drugs, natural health products and biologics, as well as medical devices.
- Ensures that scientific data supporting variations, as well as daily regulatory activities, are in compliance with all relevant regulations guidelines and policies for the impacted territories.
- Reviews and approves product labels to ensure compliance
- Bachelor Degree in Science or related field is required; Master Degree or better in Regulatory Affairs or related field preferred
- 2+ years of experience in the regulatory field within the pharmaceutical industry with a focus on CMC documentation
- Scientific knowledge
- Understanding of ICH guidelines, CTD requirements and pharmacopoeias
- Knowledge of the US and Canadian regulations and ability to interpret policies and guidelines
- Excellent communication skills across different audiences in English (essential) and French.
- Good analytical skills with high-level attention to detail and commitment to accuracy and depth.
- Adaptability in situations involving changes as well as the capacity to take action without having all the information. She/he will be able to handle multiple projects at a time.
- Ability to work independently, yet interact with various departments and people as needed. She/he must demonstrate the ability to determine, initiate and complete tasks.
- Good interpersonal skills that will allow him/her to effectively function in a fast-paced, people oriented, team environment.
- Demonstrated proficiency in using Microsoft suite (including Word, Excel and PowerPoint) and Adobe
What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
- Vacancy number: PUB249852
- Location: Montreal
- Market: Life Sciences & Health Care
- hours per week: 40
- Branch: Pharmaceutical
- Education level: Academic Bachelor
- Area of Expertise: Regulatory
- Closing date: Saturday, March 7, 2020
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