Senior Regulatory Affairs Associate
Apply NowCompany: Calea LTD.
Location: Toronto, ON M4E 3Y1
Description:
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 40,000 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 Quirnsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
We are currently seeking a full-time Senior Regulatory Affairs Associate - Product Life Cycle Management to join our team!
Hybrid role, on-site requirement 3 days/week
Location - 165 Galaxy Blvd., Toronto
Position Description:
The Senior Regulatory Affairs Associate - PLCM will be responsible for the execution of regulatory activities to support approved FKC products to ensure post-approval regulatory compliance. This position is responsible for preparation and submission of post-approval regulatory activities (supplements, annual notifications, post-DIN changes), preparation of responses to inquiries from the various regulatory agencies to support reviews of drug submissions, along with regulatory change control assessments to ensure post approval regulatory compliance of the product for Fresenius Kabi Canada Ltd. In addition, the Senior RA Associate assists the Sr. Manager, RA-PLCM in the training and guidance of junior staff members.
Qualifications:
Skills:
The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meet the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time please contact us. Fresenius Kabi Canada is an Equal Opportunity Employer.
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 Quirnsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
We are currently seeking a full-time Senior Regulatory Affairs Associate - Product Life Cycle Management to join our team!
Hybrid role, on-site requirement 3 days/week
Location - 165 Galaxy Blvd., Toronto
Position Description:
The Senior Regulatory Affairs Associate - PLCM will be responsible for the execution of regulatory activities to support approved FKC products to ensure post-approval regulatory compliance. This position is responsible for preparation and submission of post-approval regulatory activities (supplements, annual notifications, post-DIN changes), preparation of responses to inquiries from the various regulatory agencies to support reviews of drug submissions, along with regulatory change control assessments to ensure post approval regulatory compliance of the product for Fresenius Kabi Canada Ltd. In addition, the Senior RA Associate assists the Sr. Manager, RA-PLCM in the training and guidance of junior staff members.
Qualifications:
- 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
- Regulatory Affairs Certification (RAC) is an asset
- Minimum of four years of pharmaceutical experience in a regulatory affairs capacity
Skills:
- Strong communication skills (written and verbal)
- Strong focus on customer service and the ability to collaborate with all levels both inside and outside the organization
- Strong computer skills in Microsoft Office 365. Adobe Acrobat and familiarity with eCTD Document Management System are required.
- Self-motivated and able to work with minimal supervision
- Strong attention to detail with the ability to multitask and handle fluctuating workloads
- Strong organizational and problem-solving skills
- Demonstrate continuous improvement skills
- Proven ability to adhere to standards and procedures and maintain confidentiality
- Strong technical knowledge of CMC (chemistry, manufacturing and controls) requirements and ability to analyze scientific data are required
- Strong knowledge of Health Canada regulations and understanding of global regulatory requirements
- Strong commitment to quality and accuracy
- Analytical skills to assess problems and present solutions are required
The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meet the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time please contact us. Fresenius Kabi Canada is an Equal Opportunity Employer.