Senior Regulatory Affairs Associate

at  Fresenius Kabi Canada

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 Senior Regulatory Affairs Associate to join our team!

POSITION SUMMARY:

The Senior Regulatory Affairs (RA) Associate, New Product Development (NPD) reports to the Manager/Senior Manager, Regulatory Affairs NPD and MD in the Scientific Affairs department
The Senior RA Associate, NPD manages the preparation and submission of new product applications such as New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS), Drug Identification Number (DIN) and post-approval regulatory activities (supplements, annual notifications, post-DIN applications) along with regulatory change controls assessments to ensure post approval regulatory compliance of the product for Fresenius Kabi Canada Ltd. (the Company) for approved but not marketed products. In addition, the Senior RA Associate, NPD assists the Manager/Senior Manager, RA NPD and MD in the training and guidance of junior staff members.

QUALIFICATIONS & SKILLS:

• 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
• 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
  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.

Please refer the Job description for details