Senior Director, Regulatory Compliance and Operations

Role Summary

We are seeking a strategic and hands-on Senior Director, Regulatory Compliance and Operations to lead and scale our global Regulatory Operations. This is a newly created, build-and-scale role reporting into the SVP of Regulatory, Quality, and Medical Writing, and will be responsible for ensuring compliance excellence, operational efficiency, and technology enablement across the department. The ideal candidate is a proven leader with deep experience in regulatory operations and medical writing processes and operational efficiency, complemented by a strong technical background, especially in Veeva Vault RIM, document management, process automation within regulated environments and quality management.

Responsibilities

• Define and execute the global regulatory operations strategy in alignment with corporate goals
• Lead and mentor teams across all functions to ensure operational efficiency, consistency, and compliance
• Serve as a key partner to PepGen leadership to support submissions, inspections, and lifecycle management activities
• Oversee global Regulatory Information Management (RIM) systems, including Veeva Vault RIM, ensuring data integrity, traceability, governance, and compliance
• Drive submission planning and execution (publishing, submission tracking, health authority communications)
• Develop and maintain regulatory SOPs and work instructions, templates, training materials, and process maps to ensure operational excellence
• Maintain and enhance Quality Management Systems (QMS) in compliance with GxP and ISO standards
• Partner with Regulatory and Quality leadership to define and execute audit readiness initiatives (BIMO/PAI) and support regulatory inspections as needed
• Implement technology-driven process improvements using automation and analytics and promote a culture of continuous innovation
• Provide leadership oversight to the Medical Writing function to ensure high-quality, compliant, and timely deliverables (CSRs, CTD modules, labeling, etc.)
• Partner with functional teams to ensure consistency, quality standards, and document management practices across clinical and regulatory documents
• Serve as the business owner for Veeva Vault RIM, regulatory publishing tools, and document management systems
• Champion digital transformation initiatives to enhance efficiency, transparency, and compliance in document lifecycle management
• Collaborate with IT and business teams to evaluate and implement new tools supporting regulatory and quality operations
• Liaise with vendors and external peers in the industry to stay current with evolving regulatory systems technology trends

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field; advanced degree preferred
• 12+ years of experience in regulatory operations/process/compliance within the biotech or pharma industry
• Proven track record in building and leading cross-functional operations teams in global, matrixed environments
• Hands-on experience managing Veeva Vault RIM, Veeva Quality Suite, or similar systems
• Strong understanding of global regulatory frameworks (FDA, EMA, ICH)
• Excellent analytical, communication, and change management skills
• Demonstrated success in implementing process improvements and automation in regulated functions
• Experience supporting product lifecycle management and global submissions
• Passion for technology-driven compliance and operational transformation

Skills

• Regulatory Operations
• Regulatory Information Management (RIM)
• Veeva Vault RIM and Veeva Quality Suite
• Quality Management Systems (GxP, ISO)
• Regulatory submissions and lifecycle management
• Process automation and analytics
• Audit readiness and regulatory inspections
• Medical Writing oversight
• Cross-functional team leadership
• Technical aptitude with regulated systems

Education

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field; advanced degree preferred

Additional Requirements

• Role could be in-person or remote with occasional travel to the HQ office in Boston, MA