Sr. Director, Regulatory Affairs & Quality Assurance

Job Description

This position will be responsible for development, implementation and maintenance of quality assurance systems and activities. Additionally, this role will provide oversight and leadership of global regulatory affairs and corporate quality assurance activities relating to the clinical and development pipeline, including CMC and drug supply. The person in this role will advise management of any product or process related issues and make recommendations for improvements.
They will maintain understanding and compliance requirements of regulatory affairs affecting company operations and products and will be responsible for designing, implementing and maintaining an effective quality system and processes in the organization. This position will report directly to the Chief Medical Officer.

• Develop regulatory strategies to meet business objectives and ensure compliance with
regulatory requirements
• Set up quality system policies and procedures to ensure the organization is in compliance with
regulatory authority requirements (mainly FDA and EMA)
• Prepare and submit regulatory filings with relevant authorities for products
• Manage the daily operations of regulatory affairs and ensure regulatory submission compliance
and serve as regulatory authority liaison in connection with regulatory advice, submissions,
approvals, and audits
• Responsible for the Document Control process and the efficient control of all documentation
required by regulatory agencies
• Implement company trainings in GCP/GLP/GMP
• Review and interpret regulatory rules as they relate to company products and processes including product labeling
• Stay abreast of global IVD regulations and guidance, especially those relevant to Companion Diagnostics
• Management and oversight of Quality Operations, Quality Control, Supplier Quality Management, Document Control, Training, Internal Audits and CAPA subsystems
• Promote awareness of regulatory compliance and customer requirements throughout the organization and collaborate with other departments to ensure compliance quality requirement
• Ensure training of the relevant company’s functions and compliance with established regulations, guidance and SOPs related to regulations
• Monitor regulatory landscape and communicate to senior leadership any impacts of guideline and policy changes on company pipeline strategy
• Keep management informed of regulatory status of products and significant regulatory issues

Job Requirements

• Minimum of 10-12 years managing Regulatory Affairs and Quality Assurance, including in Oncology
• Experience with FDA and global biologics interactions/filings/submissions
• Experience in early drug development stage CMC activities of biologics
• In depth knowledge and experience with quality system and regulatory processes including risk management, complaint handling, regulatory submissions, CAPA, NCR supplier management, product development, design control and global registrations
• Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA. Exposure to China and EMA a plus
• Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups

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