Regulatory Affairs Associate
Montreal, Canada, Quebec, H2Z1S8
We Are Teva
Our Team, Your Impact
Regulatory Affairs Associate
Montreal, Qc
Hybrid - 3 days a week on site
This position manages the day-to-day regulatory activities for all assigned marketed products, as well as those products that are currently in development. The responsibilities of the Regulatory Affairs Associate III include compiling, organizing, and assessing documents for regulatory submissions to Health Canada as well as working with local regulatory colleagues in preparing dossiers for products for global registration. This position will support the operational activities within the RA department.
The Regulatory Affairs Associate III is also responsible for identifying and evaluating as per Health Canada requirements CMC issues associated with marketed and development products including product and process development, analytical methods, formulation development, manufacturing, and labeling. This position will liaise with development and manufacturing groups, as well as with internal departments at Teva Canada and Teva Global.
How You’ll Spend Your Day
- Provide support for major submissions (NDS and SNDS) related to pharmaceuticals, biologics and biosimilars
- Manage and/or provide support in the filing of Notifiable changes, Clinical trial applications and Administrative submissions
- Provide support in the launch activities related to newly approved products
- Update and maintain Regulatory database and systems
- Provide support in the review of promotional and non-promotional materials
- Perform other duties as assigned
- Ensure timely updates to product labelling materials, including safety updates to product monographs, associated with the different regulatory filings
- Other Duties as assigned
Your Skills and Experience
- University Degree in science related field. Preferred: Masters degree in Science
- A minimum of 3 years of pharmaceutical industry. Preferred: Experience in regulatory CMC, Quality assurance or Quality compliance with experience in a production environment
- Working knowledge of Health Canada (ICH, FDA, EMA a plus) regulations and guidance applicable to drugs and biologics.
- Strong proficiency in Microsoft Office applications
- Advanced knowledge in MS Word, Excel and PowerPoint.
- Excellent written and verbal communication skills, ideally in both French & English.
- Excellent organizational and time management skills
- Ability to work independently or in a team environment to meet strict deadlines
- Demonstrated ability to work with changing priorities that involve multiple and concurrent projects
- Detail oriented with excellent interpersonal skills with a professional attitude and the ability to interact will all levels of staff.
- Pharmaceutical industry and knowledge of GMPs regulations is a strong asset.
How We’ll Take Care of You
Already Working @TEVA?
Teva’s Equal Employment Opportunity Commitment