About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Joining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada whereby 98% of our employees are proud to say they work for AbbVie and 96% are proud of how we contribute to the community.
When choosing your career path, choose to be remarkable!
Associate Regulatory Affairs Analyst
Provide support to the Regulatory Affairs Department:
- Prepare and/or participate with filings of Canadian Drug Product Licence Applications (NDS, SNDS, NC, & CTAs)
- Manage Health Canada’s submission review process to optimize approval timelines
- Ensure maintenance of product compliance through relevant Quality and Labelling submissions
- Review and submittal of Mandatory Problem Reports in compliance with the Canadian Medical Device Regulations
- Review of Change Controls and the determination of filing requirements
- Coordinate French translations of Product Monographs and Package Inserts
- Provide support for electronic database and systems requirements, including initiation of labeling change requests
- Liaise with internal and external groups to collect necessary documents and information
- Create and maintain local Standard Operating Procedures (SOP) and Work Instructions (WI)
Minimum Requirements, Education and Experience
- B.Sc. in a relevant scientific discipline or higher degree
- Minimum 2-3 years of experience in pharmaceutical Regulatory Affairs
- Strong working knowledge of regulatory guidelines, drug development, manufacturing of pharmaceutical products
- Excellent interpersonal, cross-functional and planning skills as well as solid computer software knowledge
- Ability to work with changing priorities that involve multiple and concurrent projects
- Excellent communications, both written and oral
Equal Employment Opportunity
AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.