Senior Regulatory Affairs Associate

Fresenius Kabi Canada; Toronto; Hybrid; CAD 70,000 - 100,000; Full time

Job summary

An established industry player in healthcare is seeking a Senior Regulatory Affairs Associate to enhance product life cycle management. This hybrid role requires expertise in regulatory compliance and a strong background in life sciences, particularly in pharmaceuticals. You will be pivotal in ensuring that products meet regulatory standards while guiding junior staff. Join a passionate team dedicated to improving patient care and making a significant impact on the lives of millions. If you are detail-oriented and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• Bachelor's degree in life sciences required; regulatory affairs program is an asset.
• 4+ years of pharmaceutical regulatory experience needed.

Responsibilities

• Execute regulatory activities to support approved products.
• Prepare and submit post-approval activities and respond to inquiries.

Skills

Regulatory Affairs Certification (RAC)

Strong written and verbal communication skills

Customer service orientation

Proficiency in Microsoft Office 365

Attention to detail

Knowledge of CMC requirements

Analytical skills

Education

Bachelor of Science in Chemistry

Completion of a regulatory affairs college program

Tools

Microsoft Office 365

Adobe Acrobat

eCTD systems

Job description

Join to apply for the Senior Regulatory Affairs Associate role 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 over 40,000 employees and presence in more than 100 countries, Fresenius Kabi’s product portfolio focuses on providing access to high-quality, lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers biosimilars for autoimmune diseases and oncology. It also leads in Clinical Nutrition with a broad portfolio of enteral and parenteral products. In MedTech, the company provides infusion pumps, cell and gene therapy devices, disposables, and more. It is the global leader in blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. Its I.V. Generics and Fluids for infusion therapy save millions of lives annually in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi adopts a holistic approach to healthcare, combining experience, expertise, innovation, and dedication—making a difference in almost 450 million patients' lives each year. Under Vision 2026 and the #FutureFresenius strategy, the company aims to develop new products, expand its global presence, improve patient care, and create sustainable value for stakeholders.

Founded in 1912, Fresenius Kabi is part of the Fresenius Group, which also includes Helios and Quirónsalud. As one team, the group is committed to providing lifesaving and life-changing healthcare solutions worldwide.

We are currently seeking a full-time Senior Regulatory Affairs Associate – Product Life Cycle Management to join our team!

Hybrid role, on-site requirement 3 days/week

Location: 165 Galaxy Blvd., Toronto

Position Description

The Senior Regulatory Affairs Associate - PLCM will be responsible for executing regulatory activities to support approved FKC products and ensuring post-approval regulatory compliance. Responsibilities include preparing and submitting post-approval activities (supplements, annual notifications, post-DIN changes), responding to regulatory inquiries, and conducting change control assessments. The role also involves training and guiding junior staff members in collaboration with the Sr. Manager, RA-PLCM.

Qualifications

• Bachelor of Science in Chemistry, Microbiology, Biology, Pharmacology, or related life sciences (minimum)
• Completion of a regulatory affairs college program (asset)
• Regulatory Affairs Certification (RAC) (asset)
• At least four years of pharmaceutical regulatory experience

Skills

• Strong written and verbal communication skills
• Customer service orientation and collaboration skills
• Proficiency in Microsoft Office 365, Adobe Acrobat, and familiarity with eCTD systems
• Self-motivated with minimal supervision
• Attention to detail, multitasking, and organizational skills
• Problem-solving and continuous improvement abilities
• Adherence to standards and confidentiality
• Knowledge of CMC requirements and scientific data analysis
• Understanding of Health Canada and global regulatory requirements
• Commitment to quality and accuracy
• Analytical skills for problem assessment and solutions

The company is committed to accessibility and equal opportunity employment. For accommodations, please contact us. We value diversity and are dedicated to removing barriers in compliance with AODA.