As a global healthcare company Fresenius Kabi is Committed to Life The companys products technologies and services are used for the therapy and care of critically and chronically ill patients With more than 41000 employees and presence in over 100 countries Fresenius Kabis expansive product portfolio focuses on providing access to high quality and lifesaving medicines and technologies WHAT WE OFFER At Fresenius Kabi Canada we foster a cooperative environment where employees are encouraged to share ideas and contribute to meaningful work We offer unique learning opportunities to grow and build your career In addition we value each and every contributor and offer various benefits and rewards as applicable including Company paid health and dental benefits that start on your first day of employmentGenerous vacation planPaid float days and paid sick daysEmployee assistance programCasual office dress codeEmployee recognition programPerkopolis & Goodlife DiscountsProfessional growth and development opportunitiesWe are currently seeking a full time temporary 12 months Senior Regulatory Associate New Product Development and Medical Devices to join our team Hybrid role on site requirement 3 daysweek Location 165 Galaxy Blvd Toronto ON Pearson Airport Area The pay range for this role is 9000000 10000000 Placement within the range will be determined based on relevant skills experience qualifications and internal equity The final offer will reflect the successful candidates background and demonstrated capabilities This position is an existing vacancy within the organization MAIN RESPONSIBILITIES Participates actively in project team meetings and provides Canadian regulatory requirements to the respective functions within the project team in accordance to the current Health Canada and ICH requirementsCompiles and submits regulatory dossiers eg NDSs ANDSs SNDSs SANDSs and other applications or medical device regulatory applications in accordance to the current Health Canada guidance documents as requiredConducts accurate regulatory assessment for post approval changes for pharma and devices and identifies level of filing and data requirementsCommunicates with internal and external stakeholders to obtain application documentsSupports the Quality and Marketing Departments in the change control and product launch processes as requiredManages own projects independently as per assigned deadline and reports any delays to managementProvides regular reports to management on the status of regulatory submissions licensesclearances and registrationsQUALIFICATIONS Bachelor of Science Degree in one of Chemistry Microbiology Biology Pharmacology or other life science is required at minimumCompletion of a college regulatory affairs program is an assetMinimum of four years of pharmaceutical experience in a regulatory affairs capacity for pharma andor medical devicesSKILLS Strong knowledge of chemistry and manufacturing requirements for pharmaceuticalsStrong knowledge of Health Canada Medical Device regulations and understanding of global regulatory requirementsStrong communication skills written and verbalAble to understand customer needs and the ability to collaborate both inside and outside the organizationStrong computer skills in Microsoft Office 365 Adobe Acrobat and familiarity with eCTD Document Management System are requiredStrong attention to detailSelf motivatedProven ability to adhere to standards and procedures and maintain confidentialityStrong commitment to quality and accuracyAnalytical skills to assess problems and present solutions are requiredAbility to work well under pressure in a team based environmentMORE ABOUT US As ONE team the companies in the Fresenius Group are committed to providing lifesaving and life changing healthcare solutions on a global scale In Biopharma Fresenius Kabi offers cutting edge biosimilars for autoimmune diseases and oncology With leading market positions in Clinical Nutrition a broad portfolio of enteral and parenteral products makes a distinct difference in patients nutritional status In MedTech the company provides vital infusion pumps cell and gene therapy devices disposables and more Fresenius Kabi is the global leader in supplying blood collection bags and devices supporting blood banks and healthcare facilities worldwide The companys IV Generics and Fluids for infusion therapy help save millions of lives every year in emergency medicine surgery oncology and intensive care Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience expertise innovation and dedication making a difference in the lives of almost 450 million patients annually Inclusion and Equal Opportunity Employment At Fresenius Kabi Canada we embrace diversity and inclusion for innovation and growth We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent clients and communities We are an equal opportunity employer In accordance with the Accessibility for Ontarians with Disabilities Act 2005 and the Ontario Human Rights Code we are committed to providing accommodations and will work with candidates to meet their needs and provide an accessible candidate experience If you are a person with a disability and require assistance during the application process please let us know hrcanadafresenius kabicom We welcome members of all backgrounds experiences and perspectives to apply Artificial Intelligence AI Use in Recruitment Fresenius Kabi uses AI supported tools to help compare applicant rsums with job requirements and identify potential matches These tools do not make hiring decisions All candidate reviews selections and decisions are made by our recruitment team

📌 Senior Regulatory Associate New Product Development and Medical Devices (Canada)
🏢 Build your Future with Fresenius Kabi Canada
📍 Canada