Associate Director – Regulatory Affairs

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Contribute to global regulatory strategies and offer tactical guidance to cross-functional teams.

• Anticipate and adapt to changes in the regulatory and business environment.

• Support comprehensive regulatory planning for INDs, NDAs/BLAs, briefing packages, and orphan drug applications.

• Oversee regulatory consultants and vendors to ensure timely, compliant, and strategic deliverables.

• Act as the regulatory liaison for the FDA and other global health authorities.

• Prepare materials for and assist in agency meetings.

• Communicate regulatory risks, timelines, and updates to senior leadership and project teams.

• Represent Regulatory Affairs on Project, Clinical, and Study Teams.

• Coordinate cross-functional regulatory submission teams and stakeholder contributions.

• Identify, select, and manage vendors such as CROs.

• Ensure regulatory strategies are in compliance with applicable regulations and guidelines.

• Develop and maintain regulatory SOPs and best practices.

• Maintain regulatory intelligence and keep track of global regulatory trends, legislation, and health authority expectations.

• Participate in regulatory due diligence and provide strategic insights during business development evaluations.

⛳️ Requirements

• Bachelor’s degree in a scientific discipline or equivalent work experience is required; an advanced degree (MS, PhD, PharmD) is preferred.

• Over 7 years of experience in the pharmaceutical/biotech industry, with a minimum of 4 years in Regulatory Affairs roles.

• Required experience in oncology and across multiple development phases.

• Proven experience in preparing and supporting global regulatory submissions, particularly NDA/BLA filings with the FDA.

• Global regulatory experience is preferred.

• Strong working knowledge of the drug development process and global regulatory pathways.

• Good understanding of global regulatory guidelines and their practical application.

• Excellent interpersonal, collaboration, and leadership skills, with the capability to influence cross-functional teams.

• Highly organized with exceptional communication and project management skills to manage multiple priorities effectively.

• Proactive, analytical, and detail-oriented problem solver with a robust strategic mindset.

• Demonstrated ability to utilize AI tools for daily tasks; baseline proficiency is expected, and advanced or innovative use of AI is a strong advantage.

• Willingness to travel up to 10%.

🏝️ Benefits

• Annual target bonus.

• Equity.

• A comprehensive suite of competitive benefits designed to support employees’ overall well-being.