Sr. Director, Reg Affairs

Role Summary

As the Senior Director, Regulatory Affairs, you are a driven global regulatory leader with expertise in regulatory strategy development and execution. You excel in navigating global health authority interactions, leading cross-functional teams, and driving clinical and licensing submissions. This role reports to the QED Head of Regulatory Affairs and provides leadership in regulatory activities for assigned programs, including developing global regulatory strategies, leading submissions, and managing critical health authority interactions as well as leading regulatory staff. This is a hybrid role based in the San Francisco/Palo Alto area.

Responsibilities

• Provide leadership in creating and executing proactive regulatory strategies for product development, approval, and registration
• Apply knowledge of global quality/regulatory standards and guidelines to ensure requirements are met across programs
• Partner with internal senior leadership to align closely on cross-functional global regulatory plans and the company's short and long-term strategic objectives
• Take complete ownership of relevant regulatory submission deliverables
• Represent regulatory in senior management discussions and present strategies, recommendations, and risks accordingly
• Lead the specific Affiliate regulatory strategy team by managing, mentoring, and teaching capabilities
• Work at both high-level strategic and hands-on in leading an agile team
• Serve as key regulatory team member with responsibility for regulatory strategies and submissions lead asset
• Provide regulatory guidance and strategy for support of product development and registration strategies
• Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
• Provide leadership and oversight of the preparation of all critical global regulatory submissions (from pre-IND to post-marketing) to the FDA, EMA, and other international health authorities
• Act as the primary liaison with regulatory authorities
• Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
• Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
• Support due diligence and partnering activities, as needed
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Qualifications

• Required: Bachelor's degree in the scientific field; an advanced degree (MD, Ph.D., PharmD, MS) preferred
• Required: Minimum of 15 years of relevant pharmaceutical/biotechnology regulatory affairs experience in the pharmaceutical industry, including expertise leading a Regulatory Affairs group
• Required: Well-versed in the drug development process and regulatory requirements, plus a solid understanding of the underlying science
• Required: Strong attention to detail
• Required: Excellent written and verbal communication skills
• Required: Excellent project management skills with the ability to manage multiple projects and prioritize appropriately
• Required: Ability to rapidly understand and analyze complex problems and situations
• Required: Ability to lead teams under tight timelines and contribute significantly to day-to-day operations as needed
• Required: Comfort in a team environment and strong interpersonal skills to effectively work with others
• Required: Ability to influence without authority, lead change, solicit information, persuade others, and shape outcomes
• Required: Experience working with all levels of management and consulting with key business stakeholders (internal and external)
• Required: Willingness to travel to key meetings and Health Authority interactions as needed
• Preferred: Advanced degree (MD, Ph.D., PharmD, MS) prior to or in addition to a bachelor’s degree

Skills

• Regulatory strategy development and execution
• Global health authority interactions (FDA, EMA, etc.)
• Cross-functional team leadership
• Regulatory submissions management (IND/CTA/NDA/MAA/IDE/PMA)
• Regulatory guidance and compliance across U.S. and international requirements
• Regulatory landscape monitoring and interpretation

Education

• Bachelor's degree in a scientific field; advanced degree preferred