Step into a leadership role where your expertise drives innovation. As an Associate Director, Regulatory Affairs, you’ll guide clients through the complexities of drug, biologic, and medical device development—leading teams, shaping strategies, and ensuring successful submissions. This is your chance to be the trusted expert who turns regulations into real-world impact on global healthcare.

ABOUT YOU

If you are a strategic leader with deep knowledge of CMC regulatory expertise across both pre-and-post marketing strategies and thrive on guiding teams, solving complex regulatory challenges, and making a tangible impact on global healthcare you’ll thrive here.

To be successful we are looking for the following traits and behaviors:

• Requires a B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
• 6 years’ experience with regulatory requirements of US FDA, Health Canada and / or European authorities
• Experience with CMC regulatory pre and post marketing
• Regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU, and / or Canada

ABOUT THE ROLE

As an Associate Director of Regulatory Affairs, you will guide clients through the complexities of drug, biologic, and medical device development. You will lead and mentor regulatory teams, shape strategies, and ensure the delivery of high-quality, scientifically sound submissions. You will serve as a trusted expert in Health Authority (HA) interactions and translate regulatory requirements into clear, actionable plans. In this role, you will act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams. You will also review and author regulatory and scientific documents while driving successful outcomes for clients. Most importantly, you will make a direct impact on advancing innovative therapies and global healthcare.

YOUR MAIN RESPONSIBILITIES WILL INCLUDE BUT NOT LIMITED TO:

• Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
• Reviews and prepares HA meeting requests and briefing documents.
• Provide specialized CMC regulatory expertise across both pre-and post- marketing strategies.
• Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
• Evaluates change impact and necessary HA reporting requirements and strategies for drug products or devices from development through post-approval management.
• Has advanced knowledge of CTD format and structure for regulatory submissions.