Director of Regulatory Affairs, Drug Development
: Job Details :

About the Client:Our client is a global leader in pioneering robotic systems for the diagnosis and treatment of complex medical conditions, with a particular focus on advanced surgical interventions for solid tumors. They are at the forefront of developing cutting-edge technologies and are urgently seeking a highly qualified **Director of Regulatory Affairs** to join their dynamic R&D team. This role is critical in driving the development of innovative imaging agents, 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 submissionsStrategic Regulatory Planning: Devise and implement tailored regulatory strategies for the small molecule-focused imaging agent drug program, ensuring alignment with project goals and regulatory requirementsRegulatory 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 neededCross-Functional Collaboration: Support End of Phase (EOP) Type B meetings by collaborating across functions to develop effective strategies, meeting objectives, and briefing materialsLeadership: Provide strong leadership within the regulatory function, interfacing effectively with Clinical, Quality Assurance, and CMC teams to drive successful project outcomesQualifications and Experience:Educational Background: MS or PhD in a scientific or bioengineering disciplineIndustry 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 submissionsRegulatory 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 regulationsSpecialized Expertise: Previous experience with small molecule drug discovery is highly desirable; familiarity with regulatory considerations for medical devices is preferred But not requiredCommunication Skills: Exceptional verbal and written communication abilities, with strong presentation, teambuilding, and interpersonal skills to effectively collaborate with multiple stakeholdersCompensation and Benefits:Competitive Salary: $200K-$300K+ depending on experienceIncentive Plan: Strong bonus structureEquity Opportunities: Significant stock option awards/participationComprehensive Benefits: A generous benefits package that supports your overall well-being.Apply Now:Join a team that is transforming healthcare through innovation. Apply today to be part of this exciting journey.