Director, Regulatory Affairs

Step into a leadership role where your expertise drives innovation. As a 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 the Role

As a 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.
- Oversees and manages regulatory projects of varying complexities.
- Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
- Has advanced knowledge of CTD format and structure for regulatory submissions.