Director/Senior Director, Global Regulatory Affairs

About the Role

The Director / Senior Director of Regulatory Affairs serves as a strategic leader responsible for developing and executing regulatory strategies to support product development and commercialization. This senior position oversees reputed company regulatory activities and is responsible for ensuring compliance with global standards and timely product approvals. This position will work closely with reputed company regulatory subject matter experts, senior leadership, clinical development, manufacturing, and other internal/external stakeholders to maintain a strong regulatory culture reputed company the organization. Employment Type Full-time Reports To SVP, Clinical and Medical Affairs

Key Responsibilities

• Collaboratively reputed company and implement global regulatory strategies across clinical development and reputed company programs, including preparation and management of submissions
• Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries
• reputed company preparation and submission of regulatory documents
• Together with reputed company regulatory subject matter experts (consultants), reputed company strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, reputed company, and others to align regulatory support with business goals
• reputed company strategic input to leadership on regulatory risk and risk mitigations
• Stay reputed company with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders
• Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness
• Represent regulatory interests in product development governance committees and decision-making processes

Required Qualifications

• Advanced degree in life sciences, pharmacy, or reputed company field preferred
• 10+ years of reputed company experience in regulatory affairs reputed company the biotechnology/pharmaceutical industry
• Minimum of 5 years experience in the hematology/oncology field
• Demonstrated track record of successful regulatory submissions and agency interactions
• Comprehensive understanding of FDA, EMA, and other major health authority regulations
• Experience with successful product approvals
• Strong leadership abilities with 3+ years managing regulatory teams
• Excellent communication and interpersonal skills for effective cross-functional collaboration
• Strategic thinking with ability to translate reputed company regulatory frameworks into practical guidance
• Demonstrated ability to work collaboratively with reputed company stakeholders to reputed company reputed company in reputed company and ambiguous situations
• Deep knowledge of GxP requirements and their implementation
• Ability to operate in a fast-paced environment

Salary

• $212,000 - $290,000 (depending on experience and job level)

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