Head of Regulatory Strategy

2 weeks ago

California, United States Hamlyn Williams Full time

Hamlyn Williams is collaborating with a clinical-stage biopharmaceutical organization focused on the advancement and commercialization of cutting-edge biotherapeutics. They are seeking to add a Director of Regulatory Affairs to their team, with a hybrid work model requiring three days in the office.

Key Responsibilities

  • Offer strategic and operational guidance in regulatory affairs, encompassing regulatory strategies, clinical study prerequisites, and marketing approvals across various regions.
  • Lead and develop a high-performing regulatory team, emphasizing staff growth and succession planning.
  • Apply extensive knowledge of regulatory requirements across multiple regions to support drug development initiatives and address regulatory challenges.
  • Evaluate sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications.
  • Supervise the preparation and submission of documentation for global investigational and marketing registration, ensuring adherence to local regulations.
  • Engage with global regulatory authorities to resolve issues and accelerate approvals and labeling processes.
  • Monitor and analyze the global regulatory landscape to inform business and product development strategies.
  • Collaborate with senior stakeholders across functions to ensure regulatory strategies align with business objectives.
  • Oversee budgeting and resource planning for the regulatory department, ensuring alignment with organizational goals.

Qualifications and Skills

  • Ph.D. with over 10 years of experience in pharmaceutical regulatory affairs, or B.S/M.S. with over 12 years of relevant experience in the biotech or pharmaceutical sectors.
  • Proven experience in leading regulatory affairs across multiple major geographic areas and managing both small molecules and biologics.
  • Extensive background with INDs/CTAs, BLAs, MAAs, lifecycle management, and interactions with Regulatory Agencies, along with leading and managing regulatory teams.
  • Strong interpersonal and leadership capabilities, with the ability to work effectively in a global, cross-functional team environment.
  • Comprehensive understanding of drug development processes, regulatory requirements, and industry trends.
  • Demonstrated success in developing and implementing regulatory strategies and achieving significant regulatory milestones.
  • Strong business acumen and strategic thinking skills, capable of navigating complex challenges and contributing to the long-term vision of the organization.
  • Excellent communication abilities, with the capacity to articulate complex issues clearly and persuasively to various stakeholders.
  • Skilled in negotiation, conflict resolution, and fostering trust and respect within and outside the organization.

Benefits

  • Bonus structure
  • RSUs and options
  • Unlimited paid time off
  • 401K matching

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