Assoc Dir Regulatory Affairs

The opportunity

The Associate Director, Complex Gx, Regulatory Affairs serves as a strategic regulatory leader, responsible for independently guiding and executing all regulatory activities—both pre- and post-approval—for U.S. FDA-regulated semi-solid, transdermal, and nasal spray complex generic products. This role ensures regulatory compliance, drives operational excellence, and leads a team of regulatory professionals to deliver high-quality submissions and lifecycle management initiatives. The Associate Director acts as a key liaison with the FDA, internal cross-functional teams, and external partners. This role will also facilitate strategic alignment with FDA through early and proactive engagement during product development, enabling streamlined development pathways, mitigating regulatory risk, and accelerating time-to-market—ultimately increasing the likelihood of first-cycle approvals.

How you’ll spend your day

• Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products, specifically semi-solids, transdermals, and nasal sprays.
• Drive early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Lead regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing.
• Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
• Represent Regulatory Affairs in global and regional forums, contributing to strategic planning and regulatory alignment.
• Interpret and apply FDA regulations and guidance to both new and marketed products, ensuring compliance while fostering innovation.
• Develop and implement regulatory strategies aligned with global business objectives.
• Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
• Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
• Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
• Lead departmental planning, resource management, and policy development.
• Mentor and develop regulatory staff, supporting leadership growth and succession planning.
• Foster a culture of transparency and open communication across all levels of the organization.
• Monitor and optimize key performance indicators (KPIs), including submission timelines, quality metrics, and team development goals.
• Communicate organizational updates and priorities clearly and effectively to the team.
• Manage departmental budgets related to regulatory submissions and administrative operations.
• Serve as a delegate for senior leadership in executive forums, representing the regulatory function.
• Identify and cultivate new opportunities that align with organizational goals and future capabilities.
• Support internal and external audits and regulatory inspections as required.
• Build and maintain strong working relationships with FDA project managers.

Your experience and qualifications