Regulatory Affairs Officer (US , EU , Canada market )

Company Description

Axentra Global Pharma Compliance LLC provides fast, fixed-fee regulatory services to support domestic international companies entering the U.S. as well as Canada market. The organization serves as a U.S. FDA Agent and manages facility registration, drug listing, SPL, and MoCRA compliance for foreign cosmetics, OTC products, supplements, foods, and drugs. Axentra focuses on delivering audit-ready documentation and guidance to help clients meet U.S. regulatory expectations with confidence. Team members work in a specialized environment that emphasizes accuracy, timeliness, and client-focused solutions across diverse product categories. Role Description The Regulatory Affairs Officer (US, EU, Canada markets) is a full-time remote position . This role is responsible for preparing, reviewing, and maintaining regulatory documentation and submissions for pharmaceuticals, cosmetics, OTCs, supplements, foods, and related products. The position involves interpreting and applying regulatory requirements across U.S., European, and Canadian markets, and coordinating with internal teams and clients to ensure timely, compliant filings. Day-to-day tasks include monitoring regulatory changes, supporting facility registration and product listing activities, assisting with audit readiness, and providing clear guidance on regulatory strategies and risk mitigation. The Regulatory Affairs Officer collaborates with cross-functional stakeholders to ensure that regulatory compliance is integrated into product development, labeling, and market entry plans.

Qualifications

Strong skills in regulatory documentation and regulatory submissions, with the ability to prepare, review, and manage technical files and dossiers. Demonstrated expertise in regulatory compliance and regulatory requirements, including interpretation of U.S., EU, and Canadian regulations. Foundation in regulatory affairs, with experience supporting product registrations, listings, and interactions with regulatory authorities. Knowledge of FDA, EMA, and Health Canada guidelines relevant to cosmetics, OTCs, supplements, foods, and drugs. Bachelor’s degree in pharmacy, life sciences, regulatory affairs, or a related field; advanced degree or regulatory certification is an asset. Excellent written and verbal communication skills, with attention to detail and strong organizational abilities. Ability to work on-site, manage multiple projects and deadlines, and collaborate effectively in a cross-functional environment. Prior experience in regulatory roles within pharmaceuticals, cosmetics, or related industries is preferred.