Executive Director, Regulatory Affairs - Oncology
Hamlyn Williams is partnered with a clinical-stage biopharmaceutical company that specializes in the development and commercialization of innovative biotherapeutics.
They are looking to bring on an Executive Director, Regulatory Affairs to the team. This role with be hybrid with 3 days in office.
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.
Benefits
- Bonus
- RSUs and options
- Unlimited PTO
- 401K match
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