Director of Regulatory Affairs, Imaging Agent Drug Development

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.

Skill/Job Requirements Competency Requirements:

• Advanced degree such as MS or PhD in scientific/bioengineering field with 8-12 years of experience in Regulatory Affairs.
• Superior verbal/written communication and presentation skills, teambuilding, and interpersonal skills to work across multiple constituents.
• Previous experience supporting development of regulatory strategies for Phase 3 drug studies and their incorporation into NDAs is required.
• Possess knowledge of Good Clinical Practice and 21 CFR drug development regulations (e.g., Part 210/211, 312, 314), ICH guidelines, and other pertinent FDA regulations.
• Prior experience with phase 3 design including end of phase 2 health authority interactions. Small molecule experience is highly desired.
• Prior experience with medical devices and their regulatory considerations is preferred.
• Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
• Ability to work strategically within a business critical and high-profile development program.
• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
• Excellent ability to interact with professionals inside and outside the company.
• Entrepreneurial, collaborative, strategic thinker with excellent project management skills and ability to prioritize and plan.
• Prior experience in surgical devices and operating room procedures is preferred.
• Results-driven attitude & a resolve to win; must be self-directed with the ability to work with minimal supervision.
• Excellent interpersonal skills with emphasis on leadership, relationship development and influence management.
• Must be capable of meeting vendor credentialing requirements for working within a healthcare institution, inclusive of any vaccine requirements.
• In person work at the Sunnyvale HQ office.  Must be able to travel up to 25% of time.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.