Director of Regulatory Affairs, Drug Development

3 weeks ago

Redwood City, California, United States HealthCare Recruiters International Full time
About the Client

Our client is a pioneering leader in robotic systems for medical diagnosis and treatment, with a focus on advanced surgical interventions for solid tumors. They are at the forefront of developing cutting-edge technologies and are seeking a highly qualified Director of Regulatory Affairs to join their dynamic R&D team.

Key Responsibilities
  • Lead NDA Preparation: Oversee all New Drug Application preparation activities, coordinating closely with CROs and the internal development team to ensure timely and accurate submissions.
  • Strategic Regulatory Planning: Devise and implement tailored regulatory strategies for the small molecule-focused imaging agent drug program, ensuring alignment with project goals and regulatory requirements.
  • Regulatory Submissions Management: Take full ownership of all regulatory submissions, guiding them from initial stages through NDA approval and post-approval commitments. Ensure compliance with all relevant guidelines and engage with external consultants as needed.
  • Cross-Functional Collaboration: Support End of Phase (EOP) Type B meetings by collaborating across functions to develop effective strategies, meeting objectives, and briefing materials.
  • Leadership: Provide strong leadership within the regulatory function, interfacing effectively with Clinical, Quality Assurance, and CMC teams to drive successful project outcomes.
Qualifications and Experience
  • Educational Background: MS or PhD in a scientific or bioengineering discipline.
  • Industry Experience: 8-12 years of experience in Regulatory Affairs within a biopharmaceutical innovator environment, with a strong track record in small molecule development and NDA submissions.
  • Regulatory Knowledge: In-depth understanding of Good Clinical Practice, 21 CFR drug development regulations (e.g., Parts 210/211, 312, 314), ICH guidelines, and other pertinent FDA regulations.
  • Specialized Expertise: Previous experience with small molecule drug discovery is highly desirable; familiarity with regulatory considerations for medical devices is preferred but not required.
  • Communication Skills: Exceptional verbal and written communication abilities, with strong presentation, teambuilding, and interpersonal skills to effectively collaborate with multiple stakeholders.
Compensation and Benefits
  • Competitive Salary: $200K-$300K+ depending on experience.
  • Incentive Plan: Strong bonus structure.
  • Equity Opportunities: Significant stock option awards/participation.
  • Comprehensive Benefits: A generous benefits package that supports your overall well-being.

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