Join Jones Healthcare Group - Where Innovation Meets Purpose! This role helps ensure the secure 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.

License Management: Lead the renewal and maintenance of Health Canada Drug Establishment Licences (DEL), Natural Health Product Site Licences, Precursor Licences, and U.FDA facility registrations.

Regulatory Submissions: Prepare and manage drug listing submissions for new commercial products entering distribution. 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. 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. 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. ~ 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. ~ Regulatory Affairs Certification (RAC) is considered a strong asset. 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.

Healthcare spending account Vacation and floater days Special local discounts Employee and family assistance program Referral bonuses Jones Healthcare Group may use artificial intelligence tools to assist in the screening, assessment, or selection of candidates for this position. 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.(phone hidden) 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. #

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