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.
