Bilanzbuchhalter responsible for compliance and quality standards in financial services for Germany and Bulgaria. Focused on training, internal controls, and financial reporting.
About the role
- Regulatory Affairs Manager managing Canadian regulatory planning and execution for innovative medicines. Overseeing Health Canada submissions and collaborating with cross-functional teams for strategic planning.
Responsibilities
- 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
Requirements
- 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
Benefits
- Benefit Plan including Health, Dental, Disability, Life Insurance
- Employee Assistance Program & Virtual Health Programs
- Retirement Savings Programs
- Employee Stock Purchase Plan (ESPP)
- Paid vacation, Wellness days, Care/Sick days, Teva Days and Volunteer Days
- Education Assistance Program
- Recognition programs such as Employee Service Awards
- Employee Discounts
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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