Quality and Regulatory Director

Position Overview

The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and global regulatory requirements. As a member of the Senior Leadership Team, the Director will help guide company-wide strategy and ensure full preparedness for upcoming regulatory inspections, including a planned FDA Pre-Approval Inspection (PAI) expected in 2026.

A key focus of the role includes completing the rollout and validation of the electronic Quality Management System (eQMS) and Laboratory Information Management System (LIMS), ensuring both platforms operate in full compliance with regulatory expectations. The Director will foster a culture of inspection readiness, maintain strong relationships with regulatory authorities, and ensure cross-functional teams are aligned and well-prepared for ongoing regulatory interactions.

Key Responsibilities

Regulatory Strategy & Compliance

• Develop and lead regulatory strategies aligned with FDA, EMA, ISO, and ICH requirements.

• Serve as the organization's primary expert on regulatory matters related to novel excipients, APIs, and drug product approvals, ensuring adherence to cGMP.

• Drive all planning and preparation associated with the FDA PAI in 2026, ensuring processes and documentation meet regulatory expectations.

• Serve as the Qualified Person for batch certification and release.

eQMS & LIMS Implementation

• Lead final deployment, validation, and continuous improvement efforts for eQMS and LIMS platforms.

• Oversee system qualification and validation programs to ensure ongoing performance and regulatory compliance, including 21 CFR Part 11 requirements.

Regulatory Inspections & Audit Management

• Direct internal audit programs, gap analyses, and remediation activities in response to regulatory findings.

• Maintain a state of continuous inspection readiness, with a focus on the upcoming PAI and any additional regulatory inspections.

Quality Control, Quality Assurance & Continuous Improvement

• Lead QC and QA teams to ensure all products meet established quality standards and documentation practices.

• Manage CAPA activities and implement continuous improvement initiatives to uphold best-in-class quality performance.

Regulatory Submissions

• Prepare and manage submissions such as INDs, BLAs, CTDs, and CMC packages, ensuring accuracy, timeliness, and regulatory compliance.

• Interpret regulatory feedback and ensure prompt, appropriate follow-up actions.

Cross-Functional Partnership

• Partner with R&D, manufacturing, operations, and commercial teams to ensure alignment on regulatory requirements from early development through commercialization.

• Serve as a primary point of contact with regulatory authorities and represent the company during regulatory discussions and submissions.

Team Leadership & Development

• Lead and mentor Quality and Regulatory teams to support strong performance, technical development, and engagement.

• Recruit and retain top-tier talent while fostering a culture rooted in quality, accountability, and continuous learning.

Customer Relationship Management

• Act as a regulatory liaison for customers, providing expertise and maintaining strong professional relationships.

• Communicate regulatory expectations clearly and ensure customer needs are met with transparency and reliability.

System Compliance & Risk Management

• Establish robust risk-management practices across quality and regulatory operations.

• Proactively identify compliance risks and implement mitigation strategies.

Operational Excellence

• Drive process efficiencies, leverage technology, and streamline regulatory workflows to support timely product development and organizational effectiveness.

Qualifications & Experience

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs, or related discipline; advanced degree or MBA preferred.

• Minimum of 7 years in pharmaceutical or CDMO quality/regulatory roles, with demonstrated success in obtaining approvals for APIs, drug products, or novel excipients.

• Strong knowledge of FDA/EMA regulations, GxP requirements, and eQMS/LIMS implementation and validation.

• Hands-on experience preparing for FDA inspections, including PAIs.

• Expertise in regulatory submissions (INDs, NDAs, CTDs, DMFs, BLAs) for both chemical and biologic products.

• Proven leadership and cross-functional collaboration skills.

• Ability to build strong relationships with external partners, regulatory authorities, and customers.

• Professional proficiency in English and Spanish.

• Strong analytical, organizational, and problem-solving abilities.

• Strategic thinker with a deep understanding of operational execution.