Introduction

We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our client’s team. In this role, you will provide critical support to the Regulatory Affairs team to ensure that all products comply with applicable regulations and standards. You will assist in the preparation and submission of regulatory documentation, maintain compliance records, and facilitate communication between internal teams and regulatory authorities. This is an excellent opportunity for an individual passionate about regulatory processes and compliance within the pharmaceutical industry.

Responsibilities

• Review artwork materials against source documents to ensure accuracy and compliance with regulatory standards. Follow up on ongoing artwork projects, track progress, and ensure timely completion of deliverables.
• Support project management activities, including tracking regulatory submissions, monitoring project timelines, and managing budgets to ensure efficient operations.
• Perform precise and detailed work with a high level of accuracy. Demonstrate strong written and verbal communication skills in English (French is an asset), and collaborate effectively with internal and external stakeholders.
• Quickly learn new processes and tools, and work independently to meet deadlines and project goals with minimal supervision.
• Track and maintain regulatory submissions and approvals, ensuring accurate documentation and filing.
• Monitor and stay updated on changes in regulatory requirements and communicate relevant updates to internal teams.
• Act as a liaison between internal teams (e.g., R&D, Quality Assurance, Manufacturing) and external regulatory agencies to address inquiries and provide required documentation.
• Maintain regulatory databases and systems to ensure accurate and up-to-date records of submissions and approvals.
• Provide administrative support to the Regulatory Affairs team, including scheduling meetings, preparing presentations, and managing timelines for regulatory projects.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• 1-2 years of experience in regulatory affairs or a related field within the pharmaceutical industry is preferred.
• Familiarity with regulatory submission processes and documentation requirements.
• Awareness of labeling requirements and regulatory compliance standards.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and regulatory submission software or databases.
• Attention to detail and accuracy in reviewing and managing regulatory documentation.
• Excellent written and verbal communication skills.
• Fluency in English is required (French is an asset).
• Ability to collaborate effectively with cross-functional teams and external stakeholders.

What We Offer

Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We’ll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.