Vice President – Regulatory Affairs and Quality Assurance

East Brunswick, New Jersey

Essential Duties & Responsibilities: Quality Assurance (QA)
• Responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, and strategic objectives of the Company
• Directs and coordinates internal quality activities of documentation, incoming inspection, certificate of analysis and labelling reviews, annual product reviews, complaint and adverse event monitoring
• Directs supplier qualification program and manages external quality activities of CMOs in accordance with quality agreements
• Maintains effective CAPA process and ensures timely follow-up and implementation of corrective actions
• Responsible for overall planning and management of QA systems to ensure continuous sale of products consistent with established standards and regulatory requirements
• Conducts due diligence and ongoing supplier audits, as needed
• Acts as subject matter expert regarding all QA practices and procedures for the company as a whole
• Monitors the company’s compliance through internal and external audit programs, and provides technical and compliance oversight to the audit team
• Writes and reviews SOPs and oversees document and change control processes
Essential Duties & Responsibilities: Regulatory
• Responsible for the preparation and submission of Abbreviated New Drug Applications, including amendments, supplements, annual reports and related submission documents
• Reviews FDA correspondence regarding submissions and initiates necessary actions to ensure timely responses
• Serves as an internal resource on FDA matters for the management team, and business development, sales, supply chain and legal departments
• Directs the development of new product pipeline approval submissions to meet FDA regulatory review requirements
• Maintains approved ANDAs in compliance with FDA regulations with emphasis on strict maintenance of all annual reports and change controls
• Responsible for final release to the market and field alert/recall decisions for ANDA owned products
• Anticipates future regulatory changes, identifies risks and impact to business success, and takes action to limit the effect on Rising’s business
• Maintains an up-to-date knowledge on regulatory matters and advises senior management of potentially significant changes and risks
• Is the primary point of contact for FDA and other local regulatory agencies, and leads quality and regulatory teams to prepare for inspections and audits
• Establishes and monitors compliance with a periodic review cycle to ensure guidelines/SOPs documents are up-to-date and reflect current practice, and escalates to senior management when appropriate
• Creates implements and conducts training for all employees, and provides advice regarding FDA inspections and responding to investigators
Essential Duties & Responsibilities: Leadership
• Provides planning and leadership to staff by ensuring that appropriate structures, policies, competencies, and values are developed
• Provides leadership in developing and implementing regulatory and QA strategies and processes to ensure consistent high quality of all products
• Ensures that interfaces between regulatory/QA and other departments, particularly BD, Supply Chain, Operations, and Sales are managed optimally
• Is key contributor to business development and sales teams providing QA and compliance input to influence selection of partners and business decisions
• Interfaces with customers regarding quality and regulatory issues in support of business development and sales opportunities
• Manages decision making and conflict resolution with regard to compliance related activities

Bachelor Degree is required in  Regulatory Affairs or Pharmacy or Pharmaceutical Science.

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