Project Leader, Regulatory Affairs Labelling

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

We are currently seeking a full-time Project Leader, Regulatory Affair Labelling to join our team!

BASIC FUNCTION

The Project Leader Regulatory Affairs Labelling reports to the Senior Manager, Regulatory Affairs Labelling in the Scientific Affairs department

The Project Leader Regulatory Affairs Labelling is responsible for execution and managing technical regulatory activities. The individual, with support of the regulatory management, is a decision-maker on regulatory issues and must assure that projects deadlines are met.

In addition, the Project Leader Regulatory Affairs Labelling is responsible for training and guidance of associates ensuring adherence to the submission quality standards.

JOB RESPONSIBILITIES

• Provides strategic input and technical guidance to development teams on regulatory requirements in accordance to the current Health Canada guidance documents
• Under direction of the management, develops the regulatory strategies and cascades the appropriate detailed instructions to the associates
• Assesses Health Canada feedback on Labelling submissions to support the best regulatory technical strategy for submissions
• Reviews regulatory submissions in accordance to the current Heath Canada guidance documents
• Is responsible for reporting on progress and specific issues pertaining to regulatory activities
• Interacts with regulatory authorities during the review process to ensure submission approval
• Conducts accurate regulatory assessment for post approval changes and identifies level of filing and data requirements.
• Independently manages own projects and projects of assigned associates as per allotted deadline and reports any delays to management
• Develops, implements and manages appropriate SOPs and systems to track and manage regulatory technical tasks
• Maintains up to date knowledge of regulatory guidelines and identifies development and implementation of technical expertise withing the regulatory department. Monitors impact of changing regulations on submission strategies and update internal stakeholders

QUALIFICATIONS

• Minimum Bachelor of Science (BSc) degree in Chemistry, Pharmacy or Life Sciences, Master of Science (MSc) degree is preferred
• Completion of college regulatory affairs course is an asset
• Five to eight years pharmaceutical experience in a regulatory affairs function (two of which in personnel or project management capacity)
• Thorough understanding and detailed, sound knowledge of Canadian labeling regulatory requirements including all applicable policies and guidelines is required

SKILLS

• Excellent managerial/project organization skills
• Excellent communication skills (written and verbal)
• Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
• Self-motivated and able to work independently and monitor the associate's projects.
• Strong computer skills in MS Office and Adobe Acrobat
• Analytical skills to assess problems and present solutions are required
• Strong attention to detail with the ability to multitask and handle fluctuating workloads
• Excellent organizational and problem solving skills
• Excellent continuous improvement skills
• Ability to work well under pressure in a team-based environment
• Proven ability to adhere to standards and procedures and maintain confidentiality
• Proven initiative

The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada & Calea Ltd. are dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meeting the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time, please contact us.