Director of Regulatory Affairs

Position Summary 

The Director of Regulatory Affairs is a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline and contract manufactured products. The Director plays a leadership role in interactions with the FDA, EMEA, and other regulatory agencies to drive product approvals and maintain correspondence relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with many consultants, Exela’s contract clients and internally with several departments including R&D, Quality, Facilities, Engineering to support their initiatives. The Director of Regulatory Affairs will supervise a team of regulatory personnel in authoring, compiling, publishing and submission of regulatory dossiers. The Director of Regulatory Affairs will participate in discussions on change controls, quality holds, on-boarding new equipment and facility upgrades. 

This position initially reports to the CEO or to another senior executive, with the potential to grow into Vice President position for the right candidate.

Job Responsibilities and Leadership Skills 

• Provide leadership and direction for regulatory activities including preparing, filing, and prosecuting dossiers, responses to regulatory correspondences relating to NDAs, ANDAs, 505(b)(2) filings, clinical trial work, in multiple jurisdictions, specifically with FDA, EU, and MHRA. 
• Have strong working knowledge of change controls, quality holds, equipment on-boarding, facility expansions, and using modern quality systems such as VEEVA, LIMS, SAP. 
• Maintain current and thorough understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.
• Identify, recruit, manage, and coach/mentor full-time staff in Regulatory Affairs.
• Manage regulatory consultants, CROs, and other related third-party relationships.
• Must have exceptional inter-personal skills, customer service and self-awareness to function effectively as a team member across many departments.
• Must be willing to locate to Lenoir or to surrounding areas. This is NOT a remote job. 

Experience Requirements  

• 10 years of relevant and current work experience in pharmaceutical / biotech / CDMO industry in a fast-paced multi-jurisdictional high-quality regulatory environment 
• At least 5 years of progressive people leadership and workforce engagement.

Education Requirements 

Advanced degree in a scientific discipline but may be substituted with strong work experience.