Project Leader Regulatory Affairs, New Product

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.

**Fresenius Kabi Canada is seeking a **full-time Project Leader, Regulatory Affairs, focusing on New Product Development** to join our team**

***:
The Project Leader Regulatory Affairs, New Product Development (NPD) reports to the Senior Manager, Regulatory Affairs in the Scientific Affairs department.

The Project Leader Regulatory Affairs, NPD is responsible for the execution and management of technical and scientific regulatory activities. The individual, with support of the regulatory management, is a decision-maker on regulatory issues and must assure that project deadlines are met. In addition, the Project Leader Regulatory Affairs is responsible for training and guidance of associates, ensuring adherence to the submission quality standards.
- Provides strategic input and technical guidance to development teams on regulatory requirements in accordance with the current Health Canada and ICH standards
- Under direction of the management, develops the regulatory strategies and cascades the appropriate detailed instructions to the associates
- Evaluates proposed preclinical, clinical and manufacturing data and monitors ongoing changes to support the best regulatory strategy for submissions
- Liaises with I&D teams, internal and external stakeholders to monitor project milestones and data availability
- Authors and reviews regulatory submissions in accordance with the current Heath Canada guidance documents
- Interacts with regulatory authorities during the development and review process to ensure submission approval
- Monitors and submits applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Conducts accurate regulatory assessment for post approval changes and identifies level of filing and data requirements.
- Ensures compliance with product post marketing approval requirements
- Reviews and approves advertising and promotional items to ensure regulatory compliance
- Internally there is interaction with staff and management of all local and regional internal departments including but not limited to Finance, Human Resources, Supply Chain Management, Customer Service, Sales, Marketing, and Scientific Affairs as applicable.

**QUALIFICATIONS & SKILLS**:

- 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
- 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)
- Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
- Self-motivated and able to work independently and monitor the associate’s projects.
- Excellent continuous improvement skills
- Strong time management and ability to multitask; strong attention to details.
- Analytical skills to assess problems and present solutions are required
- Strong commitment to quality, accuracy and detail
- Ability to work well under pressure in a team-based environment
- Proficiency in Microsoft Office. Adobe Acrobat and familiar with eCTD Document Management System as required.
- Proven ability to adhere to standards and procedures and maintain confidentiality.
- 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 requi

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