Associate Director, Regulatory Affairs - Remote

Overview

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.

In Short

• Lead and mentor regulatory teams in drug and device development.
• Shape strategies for successful regulatory submissions.
• Act as a Subject Matter Expert in Health Authority interactions.
• Review and author regulatory and scientific documents.
• Provide specialized CMC regulatory expertise.
• Evaluate regulatory requirements and reporting strategies.
• Make a direct impact on advancing innovative therapies.
• Ensure high-quality, scientifically sound submissions.
• Translate regulatory requirements into actionable plans.
• Drive successful outcomes for clients.

Requirements

• Advanced knowledge of HA Regulatory Guidance & Regulations.
• Experience in preparing regulatory filings.
• Strong understanding of CTD format and structure.
• Ability to provide strategic advice and expertise.
• Experience in pre-and post-marketing strategies.
• Proven track record in evaluating change impact.

Benefits

• Opportunity to lead in a critical field.
• Impact on global healthcare advancements.
• Mentorship and leadership opportunities.
• Collaborative work environment.
• Professional growth and development.