Sr. Director / Exec. Director, Reg Affairs

Senior Director / Executive Director, Regulatory Affairs

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 on cross-functional global regulatory plans and short- and long-term strategic objectives
- Take complete ownership of relevant regulatory submission deliverables
- Represent regulatory in senior management discussions; present strategies, recommendations, and risks
- Lead the Affiliate regulatory strategy team by managing, mentoring, and teaching capabilities
- Work at both strategic and hands-on levels to lead an agile team
- Serve as key regulatory team member and regulatory strategies/submissions lead asset
- Provide regulatory guidance and strategy to support product development and registration strategies
- Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with regulatory requirements and corporate goals
- Oversee preparation of critical global regulatory submissions (from pre-IND to post-marketing) to FDA, EMA, and other international health authorities
- Act as the primary liaison with regulatory authorities
- Direct and assist internal staff and regulatory consultants to ensure compliance with U.S. and international requirements
- Analyze and communicate regulatory guidance, regulations, and industry/best-practice trends
- Support due diligence and partnering activities, as needed
- Perform duties in keeping with company policies and applicable regulations

Qualifications
- Bachelor’s degree in the scientific field required; advanced degree (MD, Ph.D., PharmD, MS) preferred
- Minimum 15 years of relevant pharmaceutical/biotechnology regulatory affairs experience in the pharmaceutical industry, including experience leading a Regulatory Affairs group

Required/Preferred Skills
- Strong knowledge of drug development process and regulatory requirements; understanding of underlying science
- Strong attention to detail; excellent written and verbal communication
- Excellent project management; ability to manage multiple projects and prioritize
- Ability to rapidly understand and analyze complex problems
- Ability to lead teams under tight timelines and contribute to day-to-day operations as needed
- Strong interpersonal skills; influence without authority; lead change
- Ability to solicit information, persuade others, and shape outcomes
- Experience working with all levels of management and consulting with internal/external stakeholders
- Travel to key meetings and health authority interactions as needed
- Curiosity and adaptability in adopting AI-powered tools and technologies

Where You’ll Work
- Remote role; requires in-office collaboration quarterly in San Francisco and Palo Alto

Benefits (as stated)
- Market-leading compensation; 401K with 100% employer match on first 3% and 50% on next 2%; employee stock purchase program; pre-tax commuter benefits; $2,500 referral award for hired referrals
- Comprehensive health care with 100% premiums covered; mental health support via Spring Health; hybrid work model; unlimited flexible paid time off; paid parental leave; flex spending accounts and group term life & disability; subsidized lunch via Forkable
- Career development and internal mobility opportunities (LinkedIn Learning, LifeLabs, Spring Health, BetterUp Coaching)

Salary (as stated)
- $270,000 - $350,000 USD