Project Leader Regulatory Affairs, Product Lifecycle Managment
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 Project Leader, Product Lifecycle Management (PLCM)to join our team.
BASIC FUNCTION
The Project Leader Regulatory Affairs - Product Lifecycle Management (PLCM) reports to the Manager/Senior Manager, Regulatory Affairs PLCM in the Scientific Affairs department.
The Project Leader Regulatory Affairs PLCM is responsible for execution and managing technical and scientific regulatory activities for lifecycle management of approved and marketed FKC products. The individual, with support of the regulatory management, is a decision-maker on regulatory issues and must assure that projects deadlines are met. In addition, the Project Leader Regulatory Affairs PLCM is responsible for training and guidance of associates ensuring adherence to the submission quality standards.
JOB RESPONSIBILITIES
QUALIFICATIONS
SKILLS
The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada & Calea Ltd. is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meeting the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time, please contact us.
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 Project Leader, Product Lifecycle Management (PLCM)to join our team.
BASIC FUNCTION
The Project Leader Regulatory Affairs - Product Lifecycle Management (PLCM) reports to the Manager/Senior Manager, Regulatory Affairs PLCM in the Scientific Affairs department.
The Project Leader Regulatory Affairs PLCM is responsible for execution and managing technical and scientific regulatory activities for lifecycle management of approved and marketed FKC products. The individual, with support of the regulatory management, is a decision-maker on regulatory issues and must assure that projects deadlines are met. In addition, the Project Leader Regulatory Affairs PLCM is responsible for training and guidance of associates ensuring adherence to the submission quality standards.
JOB RESPONSIBILITIES
- Provides strategic input and technical guidance to development teams on regulatory requirements in accordance to the current Health Canada and ICH standards
- Authors and reviews regulatory submissions in accordance to the current Heath Canada guidance documents
- Interacts with regulatory authorities during the preparation and review process to ensure submission approval
- Monitors and submits applicable deficiency responses to regulatory authorities
- Conducts accurate regulatory assessment for post approval changes and identifies level of filing and data requirements and monitors completion regulatory actions
- Ensures compliance with product post marketing approval requirements
- Maintains up to date knowledge of regulatory guidelines (Health Canada, ICH, etc.) and identifies development and implementation of technical expertise within the regulatory department
- Monitors impact of changing regulations on submission strategies and updates internal stakeholders
- Externally there is interaction with Health Canada directorates
QUALIFICATIONS
- Minimum 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
- Minimum five years of pharmaceutical experience in a regulatory affairs capacity
SKILLS
- Strong technical knowledge of CMC requirements for liquid dose, complex molecules and is able to analyze, organize and explain scientific data with the purpose of submission compilation
- Strong knowledge of Health Canada regulations and understanding of Global regulatory requirements
- Excellent communication skills (written and verbal)
- Strong attention to detail and time management with the ability to multi-task and handle fluctuating workloads
- Strong organizational and problem-solving skills
The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada & Calea Ltd. is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meeting the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time, please contact us.