Catalyst Clinical Research is hiring a
VP Regulatory Affairs and Quality Management

Summary

The Vice President of Regulatory Affairs and Quality at Catalyst is responsible for ensuring compliance with international regulatory standards, driving quality initiatives, and supporting the organization’s strategic goals. The role involves close collaboration with senior leadership, clients, and regulatory bodies to navigate complex regulatory landscapes and maintain the highest standards of quality across all operations.

Requirements

• At a minimum Bachelor’s Degree in Science or a related field. Advanced degree desirable but not required
• Minimum of 18 years’ experience in the pharmaceutical or biotechnology industry in a quality or related field
• Minimum of 12 years of Regulatory Affairs and GCP Quality experience or equivalent
• Minimum of 8 years of experience of increasing management and leadership responsibility within a global pharma or CRO organization, embracing diverse cultures and Staff
• Strong GxP knowledge and maintain a strong understanding of relevant regulatory requirements
• Proven record of developing and maintaining successful working relationships with Sponsors and regulatory agencies

Responsibilities

• Develop and implement regulatory strategies to ensure compliance with global regulatory requirements for customers development plans and operational programs
• Serve as the primary liaison with regulatory agencies, including the FDA, EMA, and other international bodies
• Develop the strategy for the preparation, submission, and maintenance of regulatory filings and documentation to meet customer commitments
• Monitor changes in regulatory environments, assess their impact on the organization, and educate the workforce
• Represent the organization at industry conferences, regulatory meetings, and client presentations
• Establish, develop, and implement the strategic quality vision, including the Quality Management Systems, at Catalyst corporately as well as the Quality Management function
• Oversee the design, implementation, and maintenance of (GxP) programs and framework, which includes the QMS maintenance, SOPs, training programs, issue management, and performing internal and external audits
• Drive continuous improvement initiatives and projects to improve processes and the QMS