We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence, because our customers deserve nothing less and our customers are at the heart of every one of our goals.
Senior Regulatory Associate New Product
Development and Medical Devices With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
We offer unique learning opportunities to grow and build your career. Company paid health and dental benefits that start on your first day of employment Generous vacation plan Employee assistance program Casual office dress code We 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 days/week Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity.
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 requirements Compiles and submits regulatory dossiers (e.g. NDSs, ANDSs, SNDSs, SANDSs, and other applications)
or medical device regulatory applications in accordance to the current Health Canada guidance documents as required Conducts accurate regulatory assessment for post-approval changes for pharma and devices and identifies level of filing and data requirements Supports the Quality and Marketing Departments in the change control and product launch processes as required Manages own projects independently as per assigned deadline and reports any delays to management Provides regular reports to management on the status of regulatory submissions, licenses/clearances and registrations Bachelor of Science Degree in one of Chemistry, Microbiology, Biology, Pharmacology or other life science is required at minimum Completion of a college regulatory affairs program is an asset Minimum of four years of pharmaceutical experience in a regulatory affairs capacity for pharma and/or medical devices Strong knowledge of chemistry and manufacturing requirements for pharmaceuticals Robust knowledge of Health Canada Medical Device regulations and understanding of global regulatory requirements Able to understand customer needs and the ability to collaborate both inside and outside the organization Strong computer skills in Microsoft Office 365®. Strong commitment to quality and accuracy 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. 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. 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 (
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📌 Senior Regulatory Associate New Product Development and Medical Devices (Toronto)
🏢 Fresenius Kabi
📍 Toronto