Senior Director, Regulatory Affairs Lead

11 hours ago


Reston, Virginia, United States Hamlyn Williams Full time

Hamlyn Williams is partnering with a pioneering biopharmaceutical company to fill a critical role in their regulatory affairs department.

Key Responsibilities

  • Provide visionary leadership in regulatory affairs, encompassing strategic planning, clinical study requirements, and marketing approvals across various regions.
  • Lead and mentor a high-performing regulatory team, focusing on staff development and succession planning to ensure a seamless transition of knowledge and expertise.
  • Utilize in-depth knowledge of regulatory requirements across multiple regions to support drug development projects and manage regulatory issues effectively.
  • Review and validate 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 and minimizing potential risks.
  • Engage with global regulatory authorities to resolve issues, expedite approvals, and negotiate favorable labeling.
  • Monitor and assess the global regulatory landscape to inform business and product development strategies, ensuring alignment with organizational objectives.
  • Collaborate with senior stakeholders across functions to align regulatory strategies with business goals, driving growth and success.
  • Manage budgeting and resource planning for the regulatory department, ensuring alignment with organizational objectives and maximizing resource utilization.

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 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.


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