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 Manager Hybrid - 3 days on‑site Scarborough, OntarioThe Regulatory Affairs Manager leads Canadian regulatory planning and execution for generic medicines, including all dosage forms, complex generics, and drug–device combination products. This role provides regulatory strategy, oversees submissions to Health Canada, supports launch preparation, and partners closely with global regulatory affairs, R&D, project management, and other internal and external stakeholders to guide activities related to the preparation and maintenance of files submitted to Health Canada. The Regulatory Affairs Manager is responsible for developing, coordinating, and implementing regulatory strategies for new products to support timely launch.How You’ll Spend Your DayLead preparation, submission and maintenance of:Abbreviated New Drug Submissions (ANDSs)Supplemental Abbreviated NDSs (sANDSs)Ensure timely updates to product labelling materials, including safety updates to product monographs, associated with regulatory filingsManage deficiency responses and timelines of submissions under reviewParticipate in regulatory meetings (pre‑submission,



dossier compilation)Act as the Canadian regulatory lead on global and local project teamsEnsure compliance to the Pharmacovigilance requirements by reporting any safety information to Teva Pharmacovigilance team as per required trainingCommunicate regulatory intelligence and review and comment on Health Canada’s evolving guidelinesEnsure adherence to Canadian regulations, ICH guidelines and internal SOPsMonitor regulatory landscape and assess impact on development programs and marketed products.Contribute to process improvements and best practices within the Regulatory Affairs function.Other duties as assignedYour Skills and ExperienceRequired: Bachelor’s degree in a science‑related field. Preferred: Master’s degree in a science discipline5 years + of experience in the pharmaceutical industryStrong background in regulatory strategy and Health Canada submissionsExperience with sterile products, complex generics, biosimilars, and drug–device combination productsProficiency in Microsoft Office applicationsStrong interpersonal skills and the ability to work independently as well as in a team environmentLeadership skills in managing submissions and projects with multidisciplinary local and global teamsKnowledge of Health Canada laws and regulationsUnderstanding of Health Canada guidances and evolving regulatory initiativesGlobal jurisdictions and ICH knowledgeSolid scientific and analytical skillsWorking knowledge of Health Canada guidelinesAbility to manage multiple priorities in a matrixed environmentHow 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 setting! The typical hiring range for this position is $99,200-$124,000.



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.Employee Assistance Program & Virtual Health ProgramsRetirement Savings ProgramsEmployee 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 DaysEducation Assistance ProgramRecognition programs such as Employee Service AwardsEmployee DiscountsAnd much more!Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.#J-18808-Ljbffr

📌 Regulatory Affairs Manager - C$99,200 - C$124,000 A Year (Toronto)
🏢 Teva
📍 Toronto