Regulatory Affairs Associate

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

Join Jones Healthcare Group - Where Innovation Meets Purpose!

Why this Role Matters

This role helps ensure the safe and compliant delivery of products that customers and patients rely on every day. It protects the integrity of our operations by maintaining critical regulatory licenses, registrations, and submissions that keep our business moving forward. It also reinforces our commitment to quality, compliance, and regulatory excellence across every stage of the product lifecycle.

As a Regulatory Affairs Associate, you'll play a key role in managing regulatory compliance activities. You'll work closely with internal teams, clients, and regulatory agencies to maintain licenses, registrations, and product submissions while supporting quality assurance initiatives that help ensure our products meet the highest standards.

What You’ll Be Accountable For

• License Management: Lead the renewal and maintenance of Health Canada Drug Establishment Licences (DEL), Natural Health Product Site Licences, Precursor Licences, and U.S. FDA facility registrations.
• Regulatory Submissions: Prepare and manage drug listing submissions for new commercial products entering distribution.
• Listing Coordination: Complete regulatory documentation, secure required authorizations, coordinate artwork approvals, and support product registration activities with regulatory agents and clients.
• Regulatory Reporting: Collect, analyze, and submit data required for annual regulatory reporting obligations, including FDA CARES Act reporting.
• Amendment Management: Prepare and file regulatory amendments related to site operations, responsible personnel changes, warehouses, and facility updates.
• Regulatory Records: Maintain accurate company and client information across regulatory databases and government systems.
• Quality Support: Contribute to quality assurance activities, complaint investigations, Annual Product Quality Reviews (APQRs), and change control assessments.
• Audit Readiness: Support client, regulatory, and internal audits by providing documentation and compliance expertise.
• Compliance Excellence: Follow all Quality Management System, Health & Safety, and Environmental Management System requirements while supporting continuous compliance initiatives.

What You’ll Bring

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
• 2+ years of experience in a pharmaceutical, biologics, or contract packaging environment.
• Experience working within a GMP-regulated environment and knowledge of pharmaceutical quality assurance and compliance practices.
• Demonstrated experience supporting Health Canada and/or U.S. FDA regulatory requirements.
• Strong attention to detail with the ability to manage multiple deadlines and regulatory timelines.
• Excellent written communication skills and the ability to collaborate effectively with clients, regulatory agencies, and cross-functional teams.
• Proficiency with Microsoft Office applications, Adobe Acrobat, and document management systems.
• Strong organizational, planning, and project coordination skills.
• Ability to work independently while contributing to a collaborative, team-oriented environment.
• Regulatory Affairs Certification (RAC) is considered a strong asset.

Why Join Jones Healthcare Group

At Jones, you’ll be part of a team that’s shaping the future of healthcare packaging with purpose and care. We take pride in fostering an environment where everyone feels valued, supported, and empowered to do their best work.

You’ll find opportunities to grow your career, contribute to meaningful projects, and be part of a company that’s been trusted by brands and healthcare providers for over a century.

Learn more about us here: www.joneshealthcaregroup.com.

Total Rewards

Benefits

We’re offering a competitive compensation in the range of $59,000 – $73,000 per year. Pay will be determined based on factors including job-related knowledge, skills, and experience. Some additional benefits we have offer are:

• RRSP program – match up to 5% of your earnings
• Comprehensive benefits program
• Healthcare spending account
• Vacation and floater days
• Special local discounts
• Employee and family assistance program
• Referral bonuses
• Education reimbursement program
• Colleague appreciation events
• and more!

This posting is for an existing opportunity.

Jones Healthcare Group may use artificial intelligence tools to assist in the screening, assessment, or selection of candidates for this position. If you have questions about this process, please contact our HR department.

While we thank all candidates for their interest, only those selected for an interview will be contacted. All candidates interviewed for this position will be notified of the hiring decision within 45 days of their last interview.

By applying for this role, you consent to your personal data being shared with our clients and partners involved in the recruitment process.

As part of our commitment to accessibility for all persons with disabilities, Jones Healthcare Group will, upon the request of the applicant, provide accommodation during the recruitment process to ensure equal access to applicants with disabilities. Please contact the Jones Human Resources department at 1.800.265.9093 about your needs, and we will consult with you to ensure suitable accommodation is provided.

For all feedback on equity and accommodation needs, please also contact the Human Resources department.