Vice President, Regulatory Affairs and Quality Assurance

JOB SUMMARY

The Vice President of Regulatory Affairs & Quality Assurance is responsible for directing the Company's global regulatory and quality assurance strategies. The VP establishes the organization's goals and objectives regarding regulatory affairs and quality assurance and ensures they are achieved. This individual is responsible for leading all submissions and communications with regulatory authorities and managing international submissions and responses. Additionally, this individual will drive the activities of the quality assurance program with a view towards phase-appropriate documentation, developing and managing internal training and SOPS, continuous improvement and implementation of corrective and preventive actions.

In this role, the VP ensures that documentation requirements for products and processes are established through change control and assures ongoing maintenance of the Quality Assurance System. This individual has the overall responsibility for managing required resources, overseeing a significant budget and meeting an aggressive regulatory submission schedule necessary to ensure the effective fulfillment of goals and objectives. The VP will partner with key stakeholders to ensure they are tied into regulatory and quality assurance strategies and execution. This position reports into the CEO.

KEY RESPONSIBILITIES

• Manages the preparation and reviews submissions to the FDA and other global health authorities.
  
• Manages international regulatory submission requirements, including the day-to-day responsibilities of regulatory submissions.
  
• Provides guidance and recommendations to key stakeholders within the organization and monitors compliance with regulatory and quality assurance requirements and commitments.
  
• Coordinates responses and interactions between the company and regulatory agencies on matters relating to Harpoon product regulatory submissions.
  
• Leads the Quality Assurance program to develop and maintain appropriate SOPs for a clinical stage development company, to oversee training of all relevant personnel, and to ensure that quality objectives are being met.
  
• Maintains up-to-date knowledge and understanding of regulatory requirements and concerns that affect the company and communicates changes to relevant personnel.
  
• Organizes and promotes company-wide quality system improvement efforts.
  
• Leads strategies for an effective document control system.
  
• Provides guidance and oversight for any product complaints and regulatory reporting.
  
• Keeps leadership apprised on the status, objectives, risks and mitigation plans associated with the various internal projects, as well as ensures regulatory teams are aware of current integrated program timelines.
  
• Remains current with regulatory intelligence and ensures submissions are aligned with current standards/expectations.
  
• Demonstrates expert knowledge of submission or technology-related global Health authority guidelines/regulations.
  
• Act as primary regulatory contact and strategist with the FDA, international regulatory agencies and other regulatory bodies.
  
• Lead, and direct Quality Operations in driving compliance activities related to FDA regulations, and quality systems standards.
  
• Provide regulatory oversight for product development, manufacturing and product expiry/retest.
  
• Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
  
• Monitor the US and international regulatory environments and provide Senior Management with assessments of the impact of new and changing regulations on the company’s business.
  
• Develop and implement training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulation.
  
• Coordinate the review and approval of product labeling
  
• Identify issues early in the submission process that could potentially impact product development
  
• Determine submission requirements and coordinate plans and timelines with Project Management
  
• Evaluate risks and safety issues and recommend regulatory solutions during the clinical phase
  
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approvals
  
• Organize, prepare and review FDA applications and other regulatory documents, including clinical study protocols/data and CMC.
  
• Monitors regulatory outcomes and provides input and advice to Senior Management Team
  
• Leads organization through regulatory due diligence
  
• Keeps ahead of domestic and international regulatory requirements and changes within the regulatory registration processes. Advises management on future domestic and international regulations.
  

QUALIFICATIONS

• 15+ years experience in Pharmaceutical QA and Regulatory Affairs
  
• Five to ten years' experience in managing personnel and complex activities. These should include experience in quality management.
  
• PharmD or PhD preferred; Bachelor’s degree required
  
• Proven ability in leading and directing regulatory affairs, compliance and quality assurance activities.
  
• Oncology experience desirable
  
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  
• Excellent communication, analytical and organizational skills.
  
• Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations and mentality of the FDA and other health authorities.
  
• Experience working with regulatory processes; particularly those employed in EU, and the USA