Company Overview

This is a life sciences company that provides a range of therapeutics and services to improve patients’ quality of life.

Title: VP of Regulatory, Quality & Clinical Affairs — JO-2205-5769

Territory: REMOTE

The VP of Regulatory, Quality & Clinical Affairs develops, leads, and drives the execution of the Company’s global regulatory, quality, and clinical research strategies and plans. The person in this role is responsible for all aspects of the Company’s Regulatory Affairs, Quality Assurance, and Clinical Affairs.

This leader oversees and approves the development and execution of the corporate strategy for Clinical Affairs as it applies to the entire portfolio of products. S/he will also oversee, approve and lead all of the interactions with Regulatory bodies as needed, and oversee, approve and implement policies, procedures, specifications, and documentation for the Quality Management System.

The VP will work and think independently; the duties of this position are to be completed under minimal to no guidance. Effective decision-making is a key component of this position, and these decisions have a significant impact on the overall success of the Company. Discretion in handling assigned responsibilities, including the ability to resolve problems and exercise good judgment is expected. Providing outstanding leadership to staff and outside consultants and contractors to augment internal resources is expected. The ability to effectively present oral and written business and technical topics and issues to a broad range of audiences, including but not limited to, the Board of Directors, Investors, Scientific Advisory Boards, and Company Executive

Leadership are essential.

Essential Duties and Responsibilities

• Develop, lead, and drive the execution of global regulatory and clinical strategy with a focus on efficient, rapid, and timely approval/registration of devices using creativity and innovation while balancing the business needs with regulatory compliance.
• Serve as a key and active member of the Company’s operational team and interact with the cross-functional team to ensure business objectives are aligned and that the Company is performing to operational objectives.
• Ensure Company compliance with regulatory agencies and all applicable standards worldwide.
• Keep the Company informed of the regulatory status of products and significant regulatory issues.
• Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and act as a liaison between the Company and regulatory authorities.
• Represent the Company before regulatory authorities.
• Oversee the preparation and filing of all regulatory documents with the FDA and international regulatory agencies.
• Responsible for Company's Quality Assurance activities to ensure compliance with regulatory agencies and all applicable standards worldwide.
• Responsible for all aspects of the Quality Management System.
• Develop and execute the quality design and quality assurance strategy.
• Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
• Responsible for review and approval of promotional, advertising, and labeling items.
• Direct the development of systems, practices, and processes to ensure effective ongoing review of complaints and adverse events.
• Provide leadership and direction for significant deviation events.
• Direct the development of systems, practices, and processes to ensure efficient and effective clinical trials, including clinical trial management, data analysis, final study report, and publication while ensuring all clinical studies operate to the highest ethical and safety standards.
• Keep abreast of competitive regulatory and clinical practices and utilize the knowledge during the ongoing development and adjustment of the Company plans.
• Responsible for cost-effective management of department budget.
• Provide guidance and leadership to the members of the team, both internal and external.
• Develop and maintain external relationships with key opinion leaders, medical directors, and regulatory officials.
• Oversee the development and management of the Regulatory, Clinical Affairs, and Quality documentation infrastructure.
• Responsible for departmental resources, including recruitment, deployment, professional development, and management of staff (internal and external).
• Performing other related duties as assigned.

Qualifications (Education & Experience)

• 20+ years of relevant and current work experience in the fields of Regulatory and Clinical Affairs and Quality Assurance.
• Demonstrated success in a regulatory, quality, and clinical team leadership capacity with a proven track record of management by influence.
• Direct experience with FDA and international agencies required.
• Knowledge of regulations and regulatory processes in applicable global markets.
• Proven excellence in operational strategy and cross-functional thinking.
• Ability to interpret, communicate, and present Regulatory, Quality, and Clinical information in a clear and concise manner to various audiences, including executive management.
• Demonstrated ability to proactively and effectively influence peers and external colleagues across all levels of management.
• Strong written and oral communication and presentation skills.

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing direct-hire and contract Medical Affairs, Regulatory Affairs, Clinical Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.