Director of Regulatory Affairs
san diego, CA
Our client is revolutionizing the pharmaceutical industry and is looking to hire a highly skilled professional for the role of Regulatory Affairs Director in San Diego, California. This person must be a highly motivated scientific leader to be a key member of this fast-paced and dynamic organization. Ability to lead regulatory submissions to ensure completeness, accuracy, compliance with agency regulations and provide regulatory CMC and quality systems guidance to assisting in defining strategies for compliance. The company has one of the strongest reputations in the clinical business to add to your career and resume.
• Directing regulatory operations related to regulatory submissions, product development, approval and commercialization
• In close coordination with the clinical development leadership, provide guidance and assist in the development of the overall global regulatory strategies regulations, appropriate scientific rationale and strategic impact
• Representing the company with domestic/international regulatory authorities, build and maintain excellent relationships with regulatory agencies, contractors and corporate partners while negotiating company position
• Identify/assess regulatory risks associated with product development and strategies to mitigate risk
• Monitor/analyze regulatory activities relevant to the company
• Perform periodic cGMP and cGLP audits of, and assist in the qualification and ongoing management of, suppliers and contract manufacturing and research organizations
• Providing regulatory support for various departments, projects, teams/committees
• Demonstrated record of successful regulatory submissions including INDs, CTAs, and NDAs, preferentially for protein-based biologics.
• Strong, working knowledge of current regulatory requirements in the US (FDA) Europe (EMEA) and other agencies.
• Capability to oversee and prepare well organized, cogent and scientifically valid document packages for regulatory submissions from all areas of company.
• Capability to conduct internal and external GMP and GLP audits and inspections.
• Experience in interfacing successfully with regulatory authorities in the US and EU.
• Experience in providing regulatory leadership to guide product development including preclinical research plans for IND submissions, early development clinical trials, late phase development strategies, and manufacturing activities (CMC, product quality, compliance, etc).
• Excellent managerial, analytical, organizational, and interpersonal communication skills.
• Ability to manage multiple projects simultaneously, and to present oral and written information in an organized and succinct manner.
• BS, MS or PhD degree in a scientific discipline with 7+ yrs experience in a regulatory drug development environment