Associate Director, Regulatory Strategy

Position Title: Associate Director, Regulatory Strategy

Reports To: Executive Director, Regulatory

Department: Regulatory

Location: South San Francisco, CA or Princeton, NJ – On site 4 days a week (Mon to Thurs)

Job Overview

Reporting to the Executive Director, Regulatory, the Associate Director, Regulatory Strategy supports the development and execution of regulatory strategies and contributes to the planning, coordination, and preparation of regulatory submissions. This role collaborates cross-functionally to ensure high-quality regulatory deliverables while operating with moderate independence and with oversight on complex deliverables.

Essential Duties and Responsibilities

• Contribute to the development and implementation of regulatory strategies for assigned development programs, with guidance from senior leadership
• Demonstrated ability to operate with increasing independence while seeking guidance on complex strategic decisions
• Plan, coordinate, and contribute to the preparation, review, and compilation of regulatory submissions in eCTD format
• Lead or support preparation of components of submissions (e.g., Module 1–5 sections) for health authorities (FDA, EMA, and global agencies)
• Review key documents (e.g., protocols, ICFs, IBs, CSRs, DSURs) to ensure alignment with regulatory strategy and compliance with applicable regulations and guidance
• Track submission timelines and deliverables to support on-time execution
• Provide regulatory input to cross-functional teams (Clinical, CMC, Nonclinical, Quality) on regulatory requirements and expectations
• Identify regulatory risks and propose mitigation strategies for review by Regulatory leadership
• Maintain awareness of evolving regulatory requirements and guidance (FDA, EMA, ICH, and global regulations)
• Ensure assigned activities comply with applicable regulatory standards and company procedures
• Support the development and review of SOPs, work instructions, and regulatory templates

Qualifications and Preferred Skills

• Bachelor’s degree required (life sciences preferred); advanced degree (MS, PhD, or PharmD) is a plus
• Minimum of 6 years of relevant experience including roles in regulatory affairs within biotechnology or pharmaceuticals
• Experience supporting regulatory submissions (e.g., INDs/CTAs, amendments, annual reports, or marketing applications)
• Working knowledge of global regulatory requirements (FDA, EMA, ICH guidelines)
• Experience contributing to or leading eCTD submissions
• Strong organizational skills and attention to detail with the ability to manage multiple priorities
• Effective communication skills and ability to work collaboratively in cross-functional teams
• Ability to communicate regulatory expectations pertaining to the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams