Regulatory Affairs Manager

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. The opportunity Regulatory Affairs Manager Hybrid, 3 days on site The Regulatory Affairs Manager leads Canadian regulatory planning and execution for innovative medicines (biologics, biosimilars and small molecules). This role provides strategic direction for clinical development programs, oversees Health Canada’s submissions, and partners closely with Global Specialty Regulatory Affairs, the TCI cross‑functional team and with R&D to support the strategic direction on activities related to the preparation and maintenance of the files submitted to the Canadian Federal Government. The professional will be responsible for developing, coordinating, and implementing regulatory strategies for new products and marketed product registrations. How you’ll spend your day - Lead the preparation, submission, and maintenance of: - Clinical Trial Applications (CTAs) - New Drug Submissions (NDSs) - Supplemental NDSs (SNDSs) - Lifecycle and maintenance activities for marketed products - Ensure timely updates to product labelling, including safety‑related changes to product monographs. - Review training materials, advertising, and promotional content for regulatory compliance. - Ensure adherence to pharmacovigilance requirements by reporting safety information to Teva’s PV team. - Lead regulatory meetings with Health Canada (pre‑CTA, pre‑submission, etc.). - Serve as the Canadian regulatory lead on global and local project teams. - Monitor and interpret regulatory intelligence; assess the impact of evolving Health Canada guidelines. - Ensure compliance with Canadian regulations, ICH guidelines, and internal SOPs. - Contribute to process improvements and best practices within the Regulatory Affairs function. Your experience and qualifications - Bachelor’s degree in a science‑related field. Master’s degree in a scientific discipline preferred. - Minimum 5 years of experience in the pharmaceutical industry - Strong background in clinical regulatory strategy and Health Canada submissions - Minimum 5 years of experience with specialty products (biologics, biosimilars, pharmaceuticals) - Proficiency in Microsoft Office applications - Strong interpersonal skills; able to work independently and collaboratively - Demonstrated leadership in managing submissions and cross‑functional projects - Solid scientific and analytical skills - Strong understanding of Health Canada regulations, guidelines, and evolving initiatives - Knowledge of global regulatory frameworks and ICH guidelines - Ability to manage multiple priorities in a matrixed environment - Organized, team‑oriented, and goal‑driven How We’ll Take Care of You At Teva Canada we provide rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment 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: - 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 offering 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. Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. 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