Regulatory Affairs Associate: Drive Submissions & Compliance

Jones Healthcare Group; Brampton; On-site; CAD 59,000 - 73,000; Full time

Benefits offered by this job

RRSP program – match up to 5% of your

Comprehensive benefits program

Healthcare spending account

Vacation and floater days

Education reimbursement program

Employee and family assistance program

Referral bonuses

Colleague appreciation events

Job summary

Jones Healthcare Group in Brampton, Canada, is seeking a Regulatory Affairs Associate to manage regulatory compliance, licenses, and submissions for pharmaceutical products. You will coordinate documentation, maintain registrations, and support quality assurance initiatives with clients and regulatory agencies.

The role requires a Pharmacy/Science degree and 2+ years in a GMP-regulated setting, with RAC considered a strong asset.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related science.
• 2+ years in a pharmaceutical, biologics, or contract packaging environment.
• Experience in GMP-regulated environments and QA/compliance practices.
• Experience supporting Health Canada and/or U.S. FDA regulatory requirements.
• Strong attention to detail with ability to manage multiple deadlines and timelines.
• Excellent written communication with clients, regulatory agencies, and cross-functional teams.
• Proficiency with MS Office, Adobe Acrobat, and document management systems.
• Regulatory Affairs Certification (RAC) is a strong asset.

Responsibilities

• License management: renew and maintain Health Canada DEL, NHPL, Precursor Licences, and FDA registrations.
• Regulatory submissions: prepare/manage drug listing submissions for new products.
• Listing coordination: complete regulatory docs, secure authorizations, coordinate artwork approvals, support registrations.
• Regulatory reporting: collect/analyze/submit data for annual regulatory reports (FDA CARES Act).
• Amendment management: prepare/file regulatory amendments for site operations and personnel changes.
• Regulatory records: maintain accurate company/client data across regulatory databases and gov systems.
• Quality support: assist QA activities, investigations, APQRs, and change controls.
• Audit readiness: support audits with documentation and compliance expertise.
• Compliance excellence: follow QMS, Health & Safety, Environmental MS requirements.

Skills

Attention to detail

Excellent written communication

Independent worker

Project coordination

Education

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

Tools

Microsoft Office

Adobe Acrobat

Document management systems

Job description

Jones Healthcare Group in Brampton, Canada, is seeking a Regulatory Affairs Associate to manage regulatory compliance, licenses, and submissions for pharmaceutical products. You will coordinate documentation, maintain registrations, and support quality assurance initiatives with clients and regulatory agencies.

The role requires a Pharmacy/Science degree and 2+ years in a GMP-regulated setting, with RAC considered a strong asset.