Job Description

Overview

: We are seeking a highly skilled Regulatory Affairs Supervisor to lead our regulatory compliance initiatives within the pharmaceutical, biotech, and natural health product (NHP) sectors. The ideal candidate will possess extensive knowledge of FDA, Health Canada, and ICH guidelines, along with strong experience in CMC, regulatory submissions, and product lifecycle management. This role offers the opportunity to oversee regulatory strategies, support product development from research to market approval, and ensure full compliance with global regulatory standards. The Regulatory Affairs Supervisor will play a key role in maintaining our company's reputation for excellence, accuracy, and regulatory integrity.

Responsibilities

Lead and manage regulatory submissions, including INDs, NDAs, ANDAs, ANDSs, NHP product license applications, site license applications, and post-approval amendments in accordance with FDA and Health Canada regulations. Plan, prepare, and coordinate CTD/eCTD submissions (Modules 1-5), ensuring high-quality and compliant documentation. Oversee compliance activities across manufacturing & controls (CMC), ensuring alignment with regulatory standards and internal SOPs. Review NHP and DIN artwork/labeling to ensure compliance with Health Canada labeling guidelines. Maintain comprehensive knowledge of Human and Veterinary ANDS submission requirements. Collaborate with R&D to support clinical trial activities and ensure documentation meets regulatory expectations. Monitor changes in regulatory frameworks (FDA, HC, ICH) and update internal procedures accordingly. Maintain internal regulatory templates, trackers, and databases in a timely and organized manner. Coordinate cross-functional teams for inspections, audits, regulatory responses, and product approvals. Provide guidance on quality assurance practices related to manufacturing and regulatory submissions. Manage project timelines to ensure timely preparation, submission, and approval of regulatory filings. Demonstrate an understanding of various dosage forms, from product development through regulatory submission stages.

Qualifications

Bachelor's degree in Chemistry, Life Sciences, or a related field; advanced degrees preferred. 3+ years of experience in Pharmaceutical Regulatory Affairs (CMC focus). Strong understanding of ICH, FDA, and Health Canada guidelines for regulatory submissions. Proven experience in coordinating and compiling regulatory submissions for human and veterinary products. Experience with NHP licensing, site license applications, and compliance with NHP/DIN labeling guidelines. Excellent technical writing and verbal communication skills. Ability to balance long-term and short-term goals while adapting to shifting priorities. Strong project management skills with the ability to work on multiple initiatives simultaneously. Demonstrated ability to work effectively within cross-functional teams. Proactive attitude with a strong desire for continuous learning and development.
Job Type: Full-time

Pay: $20.00-$30.00 per hour

Expected hours: 40 per week

Work Location: In person