Associate Director, Regulatory Affairs

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 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.
• 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.

Requirements

About You

If you are a strategic leader with deep regulatory expertise across both pre-and-post marketing stages of development and thrive on leading regulatory projects, 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 :

About Allucent

Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. Find more information about our values.

Benefits

Benefits of working at Allucent include :

Apply now!

If you are interested in this role please apply through the button or for more information reach out to Demetria Eggleston at Demetria.eggleston@allucent.com

Disclaimers :

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”