Director/Sr. Director Regulatory Affairs

Role Summary

Director/Senior Director of Regulatory Affairs who will lead global regulatory strategy and execution across all stages of drug development and registration. This role requires high-level strategic oversight and hands-on involvement in regulatory submissions. Location: San Francisco (hybrid, in-office collaboration 2-3x per week).

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

Qualifications

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

Skills

• 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 management systems

Education

• Bachelor‚Äôs degree in a scientific field required; advanced degree preferred (MD, Ph.D., PharmD, MS)