Regulatory Affairs Senior Director

This clinical stage company is pioneering advanced radiopharmaceutical treatments for cancers along with companion imagining diagnostics.  They are seeking a Regulatory Affairs Senior Director who can provide regulatory leadership and execution in all areas of development for their portfolio of radiotherapy oncology programs. Reporting into the Vice President of Global Regulatory Affairs, you will work closely with cross-functional teams and Health Authorities to advance their pipeline of programs and ensure regulatory success. This company offers innovative science, a collaborative, patient-focused company culture, and the ability to work remotely. With their lead program in Phase 1/2a studies, now is an exciting time to join this growing organization!


  • Provide regulatory strategy and execution for a portfolio of radiopharmaceutical and imaging programs.
  • Act as primary contact with the FDA and other regulatory agencies.
  • Lead the compilation, review, and submission of all lNDs, CTAs, marketing applications, and post approval amendments.
  • Apply extensive knowledge of ICH guidelines and EMA, MHRA, Health Canada, Therapeutic Goods Administration, PMDA and ROW regulations, strategically and operationally to support corporate goals.
  • Manage a team of regulatory consultants (and eventually some full time staff).
  • Ensure that contents of submission are document are complete, accurate and compliant with health authority publishing specifications, the company style guide and template specifications.
  • Contribute to improvements in department best practices and SOPs.
  • Prepare for meetings with FDA and other health authorities.
  • Performs other duties as required, interfacing with other departments, CROs, and external vendors.
  • Forecast budget based on expert understanding and industry experience.
  • Provide counsel, training, and interpretation of global regulatory guidelines.
  • Provide critical evaluation of potential product opportunities, partnering and licensing activities for business development.


  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
  • 10 or more years of experience in Regulatory Affairs for pharmaceutical drugs.
  • Extensive experience in oncology programs is required. Some experience with radiopharmaceuticals desired.
  • Experience with companion diagnostics or imaging a plus but not required.
  • Must have experience working directly with FDA and other health authorities (EMA, Health Canada, etc).
  • Experience in designing, writing, and submission of regulatory filings (INDs, CTAs, NDAs, etc) and other correspondence.
  • Strong understanding of the global pharmaceutical drug development and regulatory environment.
  • Some experience with CMC Regulatory a plus but not required.
  • Strong leadership competencies and strategic business perspectives.
  • In-depth understanding of the drug development, product commercialization and life cycle management processes.
  • Excellent oral and written communications skills.
  • Must be entrepreneurial, innovative, energetic, hands-on, and team oriented.
  • Ability to build cross-functional relationships and work collaboratively. Ability to think strategically and execute.
  • Must have good soft skills. Must have the ability to work with seasoned professionals and junior colleagues.
  • Must be flexible and comfortable with ambiguity in a small company environment.
  • Ability to travel for business. Travel up to 20% is required.


This is a remote position with up to 20% travel.     

The budgeted salary range for this position is US$250,000 to $280,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

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