Careers

At KSQ Therapeutics, we are always looking for strong leaders to join our team.
Contact us about current job opportunities.

A NOTE TO RECRUITERS

To be able to manage our flow of candidates we do not accept unsolicited resumes from any source other than directly from the candidates for current or future positions. Submission of unsolicited referrals and/or resumes in advance of a signed agreement between KSQ and the recruiter are deemed gratuitous and KSQ will not be obligated or bound in any way to pay any referral or other fees if such person is hired. Thank you in advance for your adherence to our process. For any hiring needs, pleaseĀ contact us.

Back to job listings

Head of Regulatory Affairs

KSQ Therapeutics has pioneered CRISPR-based cancer drug discovery and is now poised to enter the clinic with highly novel small and large molecule-based medicines and cellular therapies. We seek a dynamic, experienced and visionary professional to establish and lead a regulatory affairs and operations group, that will report to the Chief Medical Officer. The individual must have capacity to progress multiple KSQ medicines into the clinic and to work in a hands-on manner as s/he establishes the regulatory affairs/operations group.


Responsibilities

  • Design global regulatory strategy from pre-IND to approval for all KSQ medicines
  • Establish and lead regulatory affairs/operations group
  • Lead preparation, submission and approval of all regulatory dossiers for clinical trials including timelines
    • Pre-INDs, INDs, briefing packages, annual reports, safety reports, clinical protocols, investigator brochures, amendments, supplements, BLAs, NDAs, MAAs et al.
  • Lead transparent and proactive communications with global regulatory authorities
  • Build effective working relationships with the regulatory agency and follow-up closely on approvals of product registration and variations
  • Develop Regulatory Affairs and Operations SOPs
  • Ensure compliance with existing regulatory applications (e.g., IND maintenance including submission of Safety Reports, investigator documentation and Annual Reports)
  • Drive adherence to regulatory guidelines by monitoring changes in key global guidance documents, regulations, and directives; effectively communicate any impact of these changes on KSQ's development programs
  • Manage labelling changes, safety updates, artwork development and artwork approval of packaging material components

Requirements

  • Minimum BA/BS, preferably in a scientific discipline
  • Minimum 10+ years of regulatory affairs experience
  • Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs, NDA/BLA/MAA)
  • Knowledge and understanding of applicable global regulations, guidance documents and regulatory pathways
  • Knowledge of eCTD content/format requirements.
  • Ability to generate development options and present risk/benefit analyses to collaborate and influence cross functional teams
  • Strong interpersonal and communication skills with the ability to work effectively in a team environment via influence, collaboration and consideration of multiple view points
  • Highly motivated, independent thinker with good problem-solving ability, attention to detail and capacity to multi-task
  • Must be highly skilled in the use of MS Word, MS Project and spreadsheet programs to prepare outlines, summaries, status reports, templates and slides for distribution and communication.

Apply Now!