Director, Regulatory Site CMC

Role Summary

Director Regulatory Site CMC responsible for efficient and compliant management of regulatory change control and post-approval activities at the site level across diverse modalities, leveraging ICH Q12 principles to streamline post-approval change management and explore automation to enhance predictability and repeatability in regulatory processes. Provides centralized regulatory support for multiple manufacturing sites, including external partners, and communicates regulatory strategy to drug development, registration, and post-market support teams. Location: Boston, MA (hybrid).

Responsibilities

• Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions, ensuring compliance with global requirements.
• Apply science- and risk-based approaches guided by ICH Q12 to assess and implement post-approval changes.
• Drive adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities.
• Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
• Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.
• Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
• Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
• Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings.
• Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.
• Promote sustainable practices and scalability in site-level regulatory operations.

Qualifications

• Required: BS/BA in a scientific discipline; advanced degree (MS, PhD, etc.) preferred.
• Required: 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience; experience leading a major variation/amendment or supporting initial IND/IMPD preparation or initial NDA/BLA.
• Required: Strong practical experience with global HA requirements beyond EU/US.
• Required: Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Required: Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Required: Excellent written and oral communication skills; leadership, collaboration, negotiation, problem solving, and fostering teamwork.
• Required: Ability to analyze issues with attention to detail and to assess alternative approaches.
• Required: Proven ability to develop global regulatory strategy recommendations based on precedents, regulatory intelligence, and applicable regulations and guidelines.
• Required: Able to operate with minimal oversight, exercise good judgment, and escalate issues to line management as needed.
• Required: Demonstrates leadership, problem-solving ability, flexibility, and a commitment to teamwork; promote an inclusive culture.

Skills

• Regulatory strategy development and communications
• Global regulatory change control and post-approval management
• ICH Q12 principles and risk-based decision making
• Automation and digital tooling for regulatory processes
• Cross-functional collaboration and vendor/external partner alignment
• Change control workflows and submission management

Education

• BS/BA in a scientific discipline; MS/PhD preferred