Director of Regulatory Affairs, Imaging Agent Drug Development

2 weeks ago

Sunnyvale, United States Intuitive Surgical Full time
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.
  • They will be responsible for setting up effective goals that are meaningful to the department and impactful to the organization.  The ideal candidate will implement solutions and efficiencies for departmental process improvements and standard operating procedures.
  • The candidate will offer expert advice and training, demystifying FDA and other regulatory standards for our team, while also serving as the key intermediary between our company and regulatory authorities.
  • They will serve as the primary communicator, liaising between key internal and external stakeholders, effectively sharing regulatory strategies and issues that pertain to our small molecule-focused endeavors.  As such, they will be responsible for cross-functional collaboration on regulatory matters with various key functions within the organization.
  • Knowledge of regulatory policies and procedures for US/FDA required and knowledge of APAC and EMEA is preferred.
  • The candidate will ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
  • This individual will reinforce a culture of inclusion and diversity, and model collaborative behavior.
  • The level of the role requires independence, the ability to effectively distill complexity, and the ability to provide clear and actionable direction and information.

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