Regulatory Affairs Associate: Drive Compliance & Submissions

RXinsider LTD.; Brampton; On-site; CAD 59,000 - 73,000; Full time

Benefits offered by this job

RRSP program

Comprehensive benefits program

Healthcare spending account

Vacation and floater days

Education reimbursement

Employee and family assistance program

Referral bonuses

Job summary

Jones Healthcare Group in Brampton, Canada is seeking a Regulatory Affairs Associate to manage regulatory compliance throughout the product lifecycle. You will lead license renewals, prepare submissions for Health Canada and FDA, and coordinate documentation with regulatory agencies and clients.

The role emphasizes accuracy, cross-functional collaboration, and timely regulatory reporting; RAC is preferred. Join a dedicated team focused on quality, safety, and continuous improvement in healthcare

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• 2+ years in pharmaceutical, biologics, or contract packaging.
• Experience in GMP-regulated environment and QA/compliance practices.
• Experience supporting Health Canada and/or US FDA regulatory requirements.
• Strong detail orientation with ability to manage deadlines.

Responsibilities

• Lead license renewals and maintenance for DEL, NHPL, precursor licences, and FDA registrations.
• Prepare and manage drug listing submissions for new products.
• Coordinate regulatory documentation, authorizations, artwork approvals, and registrations.
• Collect, analyze, and submit data for annual regulatory reporting including FDA CARES Act.
• Prepare regulatory amendments related to site operations and personnel changes.
• Maintain regulatory records across databases and government systems.
• Support QA activities, APQRs, and change control assessments.
• Assist audits by providing documentation and compliance expertise.
• Follow QMS, Health & Safety, EMS requirements and drive compliance initiatives.

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related

Tools

Adobe Acrobat

Document management systems

Job description

Jones Healthcare Group in Brampton, Canada is seeking a Regulatory Affairs Associate to manage regulatory compliance throughout the product lifecycle. You will lead license renewals, prepare submissions for Health Canada and FDA, and coordinate documentation with regulatory agencies and clients.

The role emphasizes accuracy, cross-functional collaboration, and timely regulatory reporting; RAC is preferred. Join a dedicated team focused on quality, safety, and continuous improvement in healthcare