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Executive Director, Regulatory Affairs

2 months ago

Reston, Virginia, United States Hamlyn Williams Full time

Job Summary

Hamlyn Williams is seeking an experienced Executive Director, Regulatory Affairs to join their team. This is a hybrid role with 3 days in office.

About the Role

  • Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions.
  • Lead and mentor a high-performing regulatory team, focusing on staff development and succession planning.
  • Utilize deep knowledge of regulatory requirements across multiple regions to support drug development projects and manage regulatory issues.
  • Review sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications.
  • Oversee the preparation and submission of documentation for global investigational and marketing registration, ensuring compliance with local regulations.
  • Engage with global regulatory authorities to resolve issues and expedite approvals and labeling.
  • Monitor and assess the global regulatory landscape to inform business and product development strategies.
  • Collaborate with senior stakeholders across functions to align regulatory strategies with business goals.
  • Manage budgeting and resource planning for the regulatory department, ensuring alignment with organizational objectives.

Requirements

  • 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 biotech or pharmaceutical industries.
  • Experience in leading regulatory affairs across multiple major geographic areas and handling both small molecules and biologics.
  • Extensive experience with INDs/CTAs, BLAs,MAAs, lifecycle management, interactions with Regulatory Agencies, leading and managing regulatory teams
  • Strong interpersonal and leadership skills, with the ability to work effectively in a global, cross-functional team environment.
  • Comprehensive understanding of drug development processes, regulatory requirements, and industry trends.
  • Proven track record of developing and implementing regulatory strategies and achieving significant regulatory milestones.
  • Strong business acumen and strategic thinking capabilities, able to navigate complex challenges and contribute to the business's long-term vision.
  • Excellent communication skills, with the ability to articulate complex issues clearly and persuasively to various stakeholders.
  • Skilled in negotiation, conflict resolution, and building trust and respect within and outside the organization.

What We Offer

  • Bonus
  • RSUs and options
  • Unlimited PTO
  • 401K match