Regulatory Affairs Associate PLCM
Top Benefits
About the role
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. 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.
WHAT WE OFFER!
At Fresenius Kabi Canada we foster a collaborative 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 employment
- Company matched RRSP program
- Generous vacation plan with one extra day accrual for each year of service
- Paid float days and paid sick days
- Employee assistance program
- Casual office dress code
- Employee recognition program
- Perkopolis & Goodlife Discounts
- Professional growth and development opportunities
We are currently seeking a Regulatory Affairs Associate PLCM****to join our team!
Hybrid role, on-site requirement 3 days/week
Location: 165 Galaxy Blvd., Toronto, ON (Pearson Airport Area)
The pay range for this role is:****$75000-85000.
Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities.
This position is an existing vacancy within the organization.
MAIN RESPONSIBILITIES
- Prepares high-quality full or CMC part of supplemental submissions as required
- Conducts regulatory assessment and compiles regulatory documentation for the change controls to marketed products
- Prepares responses to Health Canada inquiries
QUALIFICATIONS
- Bachelor of Science degree in one of the following is required: Chemistry,
Microbiology, Biology, Pharmacology or other life science - Completion of a college regulatory affairs program is an asset
- Regulatory Affairs Certification (RAC) is an asset
- Prior experience in the healthcare or pharmaceutical industry
- Two years of pharmaceutical experience in a regulatory affairs capacity is
preferred
SKILLS
- Good knowledge of chemistry and manufacturing requirements for pharmaceuticals
- Strong communication skills (written and verbal)
- Strong attention to detail
MORE 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 company’s I.V. 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 (hrcanada@fresenius-kabi.com). 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 résumés 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.
Not the right fit? Search for Regulatory Affairs Associate PLCM jobs in Toronto, ON
About Fresenius Kabi USA
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 43,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
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 company’s I.V. 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. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.
Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
For more information, please visit www.fresenius-kabi.com/us.
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Regulatory Affairs Associate PLCM
Top Benefits
About the role
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. 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.
WHAT WE OFFER!
At Fresenius Kabi Canada we foster a collaborative 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 employment
- Company matched RRSP program
- Generous vacation plan with one extra day accrual for each year of service
- Paid float days and paid sick days
- Employee assistance program
- Casual office dress code
- Employee recognition program
- Perkopolis & Goodlife Discounts
- Professional growth and development opportunities
We are currently seeking a Regulatory Affairs Associate PLCM****to join our team!
Hybrid role, on-site requirement 3 days/week
Location: 165 Galaxy Blvd., Toronto, ON (Pearson Airport Area)
The pay range for this role is:****$75000-85000.
Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities.
This position is an existing vacancy within the organization.
MAIN RESPONSIBILITIES
- Prepares high-quality full or CMC part of supplemental submissions as required
- Conducts regulatory assessment and compiles regulatory documentation for the change controls to marketed products
- Prepares responses to Health Canada inquiries
QUALIFICATIONS
- Bachelor of Science degree in one of the following is required: Chemistry,
Microbiology, Biology, Pharmacology or other life science - Completion of a college regulatory affairs program is an asset
- Regulatory Affairs Certification (RAC) is an asset
- Prior experience in the healthcare or pharmaceutical industry
- Two years of pharmaceutical experience in a regulatory affairs capacity is
preferred
SKILLS
- Good knowledge of chemistry and manufacturing requirements for pharmaceuticals
- Strong communication skills (written and verbal)
- Strong attention to detail
MORE 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 company’s I.V. 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 (hrcanada@fresenius-kabi.com). 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 résumés 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.
Not the right fit? Search for Regulatory Affairs Associate PLCM jobs in Toronto, ON
About Fresenius Kabi USA
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 43,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
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 company’s I.V. 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. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.
Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
For more information, please visit www.fresenius-kabi.com/us.