Regulatory Affairs Associate

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:
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