Regulatory affairs specialist Jobs in Old toronto, ON

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.

Salary Range

How We’ll Take Care of You

At Teva Canada we provide a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment! The typical hiring range for this position is from $85,280-$106,600 annually. The base pay offered may vary depending on job-related knowledge, skills, experience, education, and internal equity. In addition to base salary, this role may qualify for an annual bonus based on employment type. Certain positions may also be eligible for a sales commission structure as part of the overall compensation package. Beyond base pay, Teva also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Our competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us.

As part of our commitment to well-being, employees may have access to:

• Teva Canada’s choices Benefit Plan including Health, Dental, Disability, Life Insurance
• Employee Assistance Program & Virtual Health Programs
• Retirement Savings Programs
• Employee Stock Purchase Plan (ESPP)
• Time for yourself or those you care about, through paid time for Vacation, Wellness days, Care/Sick days, Teva Days and Volunteer Days
• Education Assistance Program
• Recognition programs such as Employee Service Awards
• Employee Discounts
• And much more!

More exciting details on the specific total rewards offerings to be provided at the offer stage depending on the position and employment type hiring for. This position will fill a current vacancy and Teva Canada may use an artificial intelligence (AI) system to assist with the initial screening and evaluation of job applications by analyzing for relevant skills, professional experience, and education, that best match the posted job qualifications. It is important to note that all final decisions in this process are made by a member of the hiring team.