Director of Regulatory Affairs, Imaging Agent Drug Development

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

The purpose of the Director of Regulatory Affairs, Imaging Agent Drug Development is to lead cross functional teams in major regulatory submissions to the Center for Drug Evaluation and Research (CDER), inclusive of New Drug Applications (NDA), End of Phase (EOP) Type B meetings, health authority interactions, label discussions, and securing approvals as part of an effort to bring small molecule fluorescence imaging agents to market.  The agents are used in robotic surgical procedures with Intuitive's near infrared imaging systems to aid in critical structure and cancer visualization, enabling the surgeon to perform safer and more effective procedures.  The ideal candidate will have a broad background of experience working in the pharmaceutical sector and prior experience in several areas within regulatory affairs.  They will develop and implement the program's domestic regulatory strategy and have oversight of global regulatory submissions, working alongside consultants and internal personnel.  This will encompass both pre-market activity and eventually post-market.  The candidate will be expected to deliver regulatory milestones including an assessment of risks and mitigations, emerging data, and the probability of success. They will lead preparation of regulatory strategy documents and assist with interactions with regulatory authorities. 

Roles and Responsibilities:

• This role requires a candidate with pharmaceutical regulatory experience, ideally having previously supported lyophilized drug products and/or small-molecule API products.
• Experience supporting regulatory aspects of primarily clinical and CMC functions on a drug development team. Candidates should have experience in both clinical and CMC, or deep knowledge in one specific area with a proven track record of success.
• Lead New Drug Application (NDA) preparation activities, working in conjunction with CROs/internal development team. The ideal candidate has led multiple NDA submissions at the CDER division.
• Support End of Phase (EOP) Type B meetings. Collaborate cross-functionally to develop strategies on the meeting objectives and briefing materials.
• This role will report to the VP & Business Leader of Intuitive Fluorescence Imaging, LLC, with a dotted line to the Global VP of Regulatory Affairs and Quality Assurance (RAQA) for Intuitive.
• The role will assume leadership of FI’s Regulatory function, interfacing with FI’s Clinical, Quality Assurance and CMC functions, and Intuitive’s broader RAQA leadership.
• The ideal candidate will strategically devise and execute regulatory plans tailored to the specific needs of our small molecule-focused imaging agent drug program.
• The ideal candidate will take ownership for all regulatory submissions through to NDA and post approval commitments, ensuring adherence to regulatory requirements and guidelines and interfacing with external consultants as necessary.
• The candidate will provide direct regulatory guidance for pre-clinical, clinical, and CMC operations, fostering alignment with small molecule development protocols.
• The candidate will innovate and implement robust regulatory structures and processes, customizing them to accommodate the unique aspects of small molecule development within the context of our company.
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