. 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
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