Director/Sr. Director Regulatory Affairs

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You’ll Do

The Director/Senior Director of Regulatory Affairs will lead global regulatory strategy and execution across all stages of drug development and registration. This role requires both high-level strategic oversight and hands-on involvement in regulatory submissions. The ideal candidate is a proactive leader with deep regulatory expertise and proven experience navigating complex global regulatory landscapes in a dynamic, fast-moving pharmaceutical environment.

Responsibilities

• Lead post-marketing regulatory activities, including lifecycle management of approved products and all related amendments (e.g., labeling updates, safety variations, and manufacturing or formulation changes)
• Develop and execute forward-thinking global regulatory strategies to support late-stage development, approval, product launch and lifecycle management
• Lead interactions with health authorities, including preparation for regulatory meetings, managing agency correspondence, and coordinating timely responses to inquiries
• Act as the lead regulatory affairs representative in the planning and conduct of international clinical trials, ensuring alignment with global regulatory requirements and ethical standards
• Serve as the regulatory lead in senior leadership and cross-functional forums, ensuring alignment on regulatory objectives, risks, and opportunities
• Provide expert guidance to internal teams on regulatory pathways, requirements, and best practices across global markets (e.g., FDA, EMA)
• Oversee the planning, preparation, and timely submission of high-quality regulatory filings, including INDs, CTAs, NDAs, MAAs, and associated amendments or supplements
• Collaborate with project managers to develop and maintain regulatory submission timelines, ensuring deliverables are completed on schedule and aligned with program priorities
• Partner with external stakeholders and vendors to coordinate submissions and ensure compliance with regulatory requirements
• Lead or contribute to the development and maintenance of regulatory SOPs and internal guidance documents
• Support due diligence and partnering activities as needed

Where You’ll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.

Who You Are

• A Bachelor’s degree in a scientific field is required; an advanced degree (MD, Ph.D., PharmD, MS) is preferred
• A minimum of 15 years of relevant experience in pharmaceutical/biotechnology regulatory affairs, including leadership of a Regulatory Affairs group
• Strong attention to detail, with the ability to manage multiple projects under tight deadlines and work independently
• Proven experience leading eCTD-formatted submissions (e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements) for drugs and/or biologics
• Demonstrated success in leading responses to health authorities and other critical submissions while meeting agreed timelines

Special Skills / Knowledge:

• Excellent oral and written communication skills, along with strong time management abilities
• Proven ability to work effectively with, and/or lead, cross-functional teams (e.g., research, clinical, and CMC teams)
• Skilled in developing regulatory plans and strategies while proactively identifying and mitigating risks
• Capable of managing multiple tasks with strong attention to detail to support company objectives
• Solid knowledge of ICH, GCP, GMP, and other relevant global regulatory guidelines
• Proficient in computer applications such as MS Word, Excel, PowerPoint, and electronic document m