Senior Manager, Regulatory Affairs

« Go Back

Employment Status: Full-Time

About Sapience Therapeutics

At Sapience, we think boldly about the possibilities for treating cancer. We aim to discover and develop peptide therapeutics to address oncogenic and immune dysregulation that drive cancer. To accomplish this goal, we are developing next generation peptide therapeutic candidates called SPEARS (Stabilized Peptides Engineered Against Regulation) to drug oncogenic transcription factors and regulatory pathways of disease that make cells cancerous or dampen the immune systems response against tumors. Our lead compound, ST101, is currently in the Phase 2 portion of a Phase 1/2 clinica trial and has demonstrated clinical proof-of-concept in cutaneous melanoma and recurrent GBM.

Position Summary:

Sapience is currently seeking a Senior Manager of Regulatory Affairs to join our growing team.  He/she will be responsible for working closely with functional areas (nonclinical, clinical, CMC) to support product development and approval, provide strategic and operational leadership on project teams and manage/maintain regulatory filings.


Responsibilities will include support to new and on-going programs including:.

  • Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.
  • Lead regulatory subteams.
  • Conduct and analyze regulatory research on precedent and competitive products to understand product positioning and inform regulatory strategy.
  • Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development programs.
  • Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks.
  • Develop and/or review regulatory documents to ensure that all submissions are of high quality.
  • Define content/prepare/coordinate/file/manage regulatory applications (IND/CTA, NDA/BLA/MAA, orphan, fast track, etc.), annual reports, and information amendments
  • Interface with global regulatory authorities and consultants.
  • Coordinate, prepare for and conduct Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
  • Interface with functional areas (CMC, nonclinical, clinical) to identify and obtain information required for regulatory submissions.
  • Provide critical review of documents (SOPs, protocols, and reports) related to clinical, nonclinical or manufacturing, as necessary.
  • Maintain knowledge of current global rules, regulations, and guidances governing drugs and biologics in all phases of development,  as well as knowledge of therapeutic area.
  • Interpret new and existing regulations and guidance documents for regulatory department and project teams.


  • MS, PhD., PharmD BA/BS degree in life sciences or experience in drug development that allows for sufficient knowledge in this area.
  • Strong scientific background with at least seven years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
  • Prior experience with product development in a project management role with relevance to early phase non-clinical, clinical and/or CMC drug development.
  • Excellent attention to detail with solid coordinating, task planning and time management skills.
  • Outstanding verbal, written and interpersonal communication skills.
  • Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
  • Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies.
  • Thorough understanding of global drug development regulations and guidelines.
  • Proven ability to successfully manage major submissions and critical projects to deadlines.
  • Proven ability to successfully interact with regulatory authorities.

What We Offer

  • A diverse and inclusive culture where ideas are shared and your authentic self is welcome
  • Exceptional, collaborative, dedicated team
  • The chance to participate in work which may have a transformational impact on millions of people
  • Continuous learning and dynamic challenges to help you grow and be the best version of yourself
  • Comprehensive health/dental/vision insurance, 401k match, stock options, PTO

How to Apply

To apply online, please fill out the form below. If you prefer to send a letter, resume or curriculum vitae to please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.

Sapience Therapeutics is an equal opportunity employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds.