Director, Clinical Regulatory Affairs

Position Summary

Cardinal Health Regulatory Sciences delivers proven regulatory consulting expertise to help pharmaceutical manufacturers obtain global product approval and maintain filings throughout the product lifecycle.  Over the past four decades, our team of more than 150 industry-trained regulatory consultants has provided expert guidance to help pharmaceutical, biotech and medical device companies get their products to market quickly.

Director, Regulatory Affairs (Clinical Submissions) is responsible for ensuring compliance with regulatory requirements for clinical trials and products. This role involves providing strategic regulatory support across the lifecycle of clinical research, development of clinical development plans, development of regulatory paths for products, preparing and managing regulatory submissions, and acting as a liaison between the organization and regulatory agencies.  This role leads a team of clinical regulatory consultants.

This is a remote, work from home position with travel up to 25%.

This position reports to the Director, Global Regulatory Affairs.

Responsibilities   

• Regulatory Submissions & Documentation Preparation - review, and manage the submission of regulatory, clinical documents, including INDs, NDAs, BLAs, CTAs, and other filings to regulatory authorities (FDA, EMA, etc.).
• Manage and ensure timely submission of regulatory, and clinical documents to meet project timelines and milestones.
• Maintain regulatory filings and documentation in accordance with regulatory agency requirements and internal standards.
• Regulatory Compliance - ensure ongoing compliance with applicable regulations (e.g., FDA, EMA, ICH, GxP) throughout the life cycle of clinical development.
• Monitor and interpret changes in regulatory policies, guidance, and legislation and communicate relevant updates to stakeholders.
• Support audits and inspections from regulatory bodies.
• Regulatory Strategy Development - lead the development and implementation of regulatory strategies to support clinical trial designs, product development, and commercialization.
• Provide regulatory input and review or preparation of clinical trial protocols, labeling, meeting documents, and product dossiers.
• Ensure alignment with global regulatory requirements for clinical trials and marketing applications.
• Cross-functional Collaboration - work closely with clinical operations, project management, medical affairs, legal, medical writing, nonclinical, and quality teams to ensure regulatory compliance in clinical trial execution and product development.
• Provide regulatory guidance and advice to cross-functional teams to support clinical trial design, implementation, and data interpretation.
• Regulatory Agency Interaction - serve as the primary point of contact or US Agent for regulatory authorities for assigned products or projects.
• Represent and lead the organization in meetings with regulatory authorities to resolve issues and negotiate submission requirements or timelines.
• Leadership & Team Development - lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory processes.
• Contribute to the development and improvement of internal regulatory processes and standard operating procedures (SOPs).

Qualifications

• Master's degree in life sciences, pharmacy, or related field preferred; advanced degree (MS, MD, PhD, or JD) preferred
• 10+ years of regulatory affairs experience with demonstrated leadership responsibilities preferred.
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.) and clinical trial regulations.
• Experience with preparation and review of regulatory submissions (e.g., INDs, NDAs, CTAs) and interactions with regulatory authorities, preferred.
• Proficiency in regulatory affairs software, writing software, and electronic eCTD submission systems, highly preferred.
• Proficient in the preparation/authoring and review of regulatory and clinical documents (etc. Module 1 admin and labeling documents, Module 2 clinical documents, and Module 5 clinical documents), highly preferred.
• Ability to prepare meeting documents, lead FDA meetings and actively participate, including experience preparing designation requests for FDA, highly preferred.
• Prior client facing experience, preferred.
• Strong problem-solving and decision-making skills with a high attention to detail.
• Experience with drugs and biologics, with medical devices or combination products, highly preferred.
• RAC certification, preferred.
• Experience in managing global regulatory submissions and verbal and written interactions with regulatory agencies, preferr