Hamlyn Williams is partnered with an early stage biopharmaceutical company that specializes in the development and commercialization of innovative biotherapeutics. They are looking to bring on a Senior Director, Regulatory Affairs to the team.

Key Responsibilities

• 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.

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.