Senior Regulatory Affairs Associate (Contract, 12-Months)

at  Fresenius Kabi Canada

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

POSITION SUMMARY:

The Senior Regulatory Affairs (RA) Associate, New Product Development (NPD) reports to the 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 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 4 years of pharmaceutical experience in a regulatory affairs capacity
• Strong knowledge of Health Canada regulations and understanding of global regulatory requirements
• 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