Project Leader Ra, Product Lifecycle Management

3 months ago

Toronto, Canada Fresenius Kabi Canada Full time

If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Fresenius Kabi.

We are an employer that works to build great leaders, teams and businesses. We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential and the opportunity to work with managers who care about their professional development. 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.

As a part of Fresenius Kabi you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you.

**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._

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