Senior Associate, Regulatory Affairs PLCM

Job 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 41,000 employees and presence in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

Position Description
The Senior Regulatory Affairs Associate - PLCM will be responsible for the execution of regulatory activities to support approved 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 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

WHAT WE OFFER
Benefits
At Fresenius Kabi Canada we foster a collaborative environment where employees are encouraged to share ideas and contribute to meaningful work. We offer unique learning opportunities to grow and build your career. In addition, we value each and every contributor and offer various benefits and rewards (as applicable) including:

• Hybrid work model
• Health and dental benefits that start on your first day of employment
• Company matched RRSP program
• Generous vacation plan with one extra day accrual for each year of service
• Paid float days and paid sick days
• Employee assistance program
• Casual office dress code
• LinkedIn learning subscription
• Employee recognition program
• Professional growth and development opportunities

MORE ABOUT US
As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

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.