Regulatory Affairs Director
1 week ago
Hamlyn Williams is partnering with a clinical-stage biopharmaceutical company to bring on an Executive Director, Regulatory Affairs to lead their regulatory affairs 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 and ensure compliance with regulatory requirements for global submission documents, including IND/CTA, BLA/MAA, and other global submission documents.
- 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.
- 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 regulatory submissions, lifecycle management, and interactions with Regulatory Agencies.
- 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.
- Bonus
- RSUs and options
- Unlimited PTO
- 401K match
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