Senior Regulatory Associate at Fresenius Kabi

Advance your career as a Senior Regulatory Associate at Fresenius Kabi Canada, focusing on new product development and medical devices in a hybrid work environment. Join a team committed to life and high-quality healthcare solutions.

This full-time temporary role requires a minimum of four years of pharmaceutical regulatory experience, encompassing both pharma and medical devices. As a Senior Regulatory Associate, you will provide critical guidance on Canadian regulatory requirements and compile and submit necessary regulatory dossiers. Your ability to communicate effectively with internal and external stakeholders, coupled with a strong attention to detail, is essential for success.

Key Responsibilities:

• Participate in project team meetings and share regulatory insights

• Compile and submit regulatory applications per Health Canada guidelines

• Conduct assessments for post-approval regulatory changes

• Communicate with stakeholders for application documents

• Manage projects independently and report progress

Requirements:

• Bachelor’s degree in Chemistry, Microbiology, or related field

• Completion of a regulatory affairs program is beneficial

• Minimum four years of regulatory experience in pharma or devices

• Strong knowledge of Health Canada regulations

• Excellent written and verbal communication skills

Utilize your regulatory expertise to make a difference in patient care at Fresenius Kabi.