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.

WHAT WE OFFER!

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
• Comprehensive 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

Join us as a full-time Senior Regulatory Affairs Labelling Associate!

JOB DESCRIPTION

• Adheres to corporate, regulatory and individual responsibilities supporting the Company’s quality management programs, supporting policies, procedures, work instructions, and relevant software
• Creates initial Product Monograph/Package Insert for initial and supplemental product submission, Product Monograph/Package Insert updates, based on CRP or internal driven changes, e.g. request from marketing, or safety trends from corporate safety group
• Prepares Structured Product Monograph
• Provides support to junior staff for proper preparation of Structured Product Monograph
• Creates initial vial/syringe/bag/carton labels for initial product submission and supplements
• Makes updates to vial/syringe/bag/carton labels based on internal request from marketing, as a result of complaints, or change in die lines due to change in manufacturing sites/equipment, or company administrative changes
• Monitors safety updates on the Health Canada website
• Prepares fling of Annual Notification/Labelling S/ANDs label changes for PLL and PLCM Projects to manage regulatory product life cycle
• Manages response to deficiencies inquires in timely manner
• Works with Quality and Marketing teams to create the labelling mock- ups
• Works with Medical Information to obtain the literature articles needed to support the PM text and updates, as required
• Coordinates PV department's review of the PM/PI, as needed
• Updates appropriate regulatory tracking systems
• Maintains the SOPs and checklists for labelling
• Coordinates business notification for labeling submissions and approvals (e.g. Quality, Supply Chain Management and Marketing teams)
• Conducts accurate assessment for post-approval changes and identifies the impact on the labels and level of filing Assists Manager, RA Labelling in reviewing submission and change assessments prepared by junior staff
• Provides training and guidance to junior regulatory staff
• Maintain up-to-date knowledge of regulatory guidelines
• Supports development and implementation of departmental and cross-functional process improvement
• Make on time decisions to enforce compliance if needed
• Prepare quality submissions to receive the minimum deficiencies from Health Canada and enhance the approval process
• 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
• Externally there is interaction with suppliers and service providers (API suppliers, component suppliers, translators, contract laboratories, etc.). Interaction can extend to regulatory authorities with manager’s approval
• Contributes to departmental KPIs, like maintaining product compliance and company growth
• Perform other duties as assigned

QUALIFICATIONS

• 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 of four years pharmaceutical experience in a regulatory affairs capacity
• Strong computer skills in Microsoft® Office and Adobe Acrobat

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.

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.

Inclusion and Equal Opportunity Employment

At FKC and Calea, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent, clients and communities.
We also strive to provide an accessible candidate experience for our prospective employees with different abilities. Please let us know if you need any accommodations during the recruitment process.

FKC and Calea are equal opportunity employers and are committed to Equity, Diversity, Inclusion and Anti-Racism. We believe diverse and inclusive teams support strong decision making, fosters a culture of belonging and allows us to better serve our people, residents and community. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, we are committed to providing accommodations and will work with employees to meet their needs through the recruitment process. If you are a person with a disability and require assistance during the application process, please let us know. We embrace an inclusive work environment and welcome members of all backgrounds, experiences and perspectives to apply.

#committedtolife