Associate Director/Director Regulatory Affairs

Associate Director, Regulatory Affairs
Location: Boston, MA (Hybrid or East Coast, USA)
Employment Type: Full-time, Permanent

About the Company
Our client is a growing consultancy supporting innovative biotechnology and pharmaceutical companies across all stages of development. They are known for helping clients achieve regulatory success through deep scientific understanding and pragmatic regulatory strategy.

Role Overview
We are seeking an experienced Associate Director of Regulatory Affairs who brings strong hands-on expertise in U.S. regulatory submissions. This is a strategic and execution-focused role suited for someone who thrives in a client-facing environment, enjoys variety, and wants to remain closely involved in submission delivery.

This position is hands-on with no direct reports, working across multiple client programs and supporting regulatory strategy and execution from early development through product registration.

Key Responsibilities

• Develop and implement U.S. regulatory strategies for biotechnology and pharmaceutical programs from early to late stage.

• Prepare, author, and manage regulatory submissions including INDs, NDAs, and BLAs.

• Support client interactions with the FDA, including preparation for and participation in pre-IND, Type B, and Type C meetings.

• Contribute to the preparation of documentation such as PSPs, Orphan Drug Designations, and expedited program applications.

• Provide regulatory guidance across multidisciplinary teams including CMC, clinical, and nonclinical functions.

• Monitor U.S. and global regulatory trends, advising clients on implications for their programs.

• Serve as a trusted regulatory partner to clients, balancing tactical execution with strategic thinking.

Qualifications

• Minimum of 10–12 years’ experience in Regulatory Affairs supporting biologics or pharmaceutical development.

• Proven experience preparing and managing major regulatory submissions (INDs, NDAs, BLAs).

• Strong knowledge of FDA processes, meetings, PSPs, and Orphan Drug regulations.

• Excellent communication and interpersonal skills, confident in working directly with clients and cross-functional teams.

• Demonstrated ability to operate autonomously in a consultancy or fast-paced environment.

Desirable Experience

• Exposure to EU regulatory or other international submissions.

• Experience with medical device or combination product submissions.

• Understanding of CMC and/or nonclinical regulatory requirements.

Why Join

• Opportunity to work with diverse, cutting-edge biotech and pharma innovators.

• Blend of hands-on project delivery and strategic client engagement.

• Collaborative, science-driven consulting culture with genuine autonomy.