Regulatory Affairs Director
2 months ago
Our client is a pioneering company in the field of robotic systems for medical diagnosis and treatment, with a focus on advanced surgical interventions for complex conditions.
Job SummaryWe are seeking a highly qualified Director of Regulatory Affairs to join our dynamic R&D team. This role is critical in driving the development of innovative imaging agents and ensuring their successful navigation through regulatory pathways.
Key Responsibilities- Lead NDA Preparation: Oversee all New Drug Application (NDA) 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.
We are looking for a candidate with:
- 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.
We offer a competitive salary, strong bonus structure, and comprehensive benefits package that supports your overall well-being.
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