Regulatory Affairs Associate III

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

Regulatory Affairs Associate
Montreal /Toronto
Hybrid - 3 days a week on site

This position manages the day-to-day regulatory clinical/labelling 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 clinical/labelling 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 would require having a good knowledge in 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 clinical/labelling regulatory support for major submissions (NDS and SNDS) related to pharmaceuticals, biologics and biosimilars
• Manage and/or provide support in the filing of, clinical and labelling SNDS(s), Notifiable changes, Clinical trial applications and Administrative submissions
• Provide support in the review of promotional and non-promotional materials
• Ensure timely updates to product labelling materials, including safety updates to product monographs, associated with the different regulatory filings
• Provide support in the launch activities related to newly approved products
• Update and maintain Regulatory database and systems
• Perform other duties as assigned
• 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

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.