Director of Regulatory Affairs

ABOUT US
Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs' drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team.

POSITION TITLE: Director of Regulatory Affairs

POSITION SUMMARY:

Calibr-Skaggs is seeking an experienced and strategic Director of Regulatory Affairs to lead regulatory strategy and execution across our preclinical and early clinical development programs. This individual will develop and execute global regulatory strategy, ensuring alignment of U.S. and international development pathways to support efficient progression from IND through Phase 2 and into potential registrational development.

The Director will be responsible for regulatory submissions (including INDs), regulatory reporting for preclinical and clinical programs, orphan and fast track designation applications, oversight of toxicology reporting, and development of integrated regulatory strategies aligned with long-term development and commercialization goals.

The successful candidate will operate as a core strategic partner to scientific and executive leadership, with direct responsibility for global health authority engagement and long-term development planning across major markets.

RESPONSIBILITIE & DUTIES:

Regulatory Strategy & Leadership:

• Develop and execute U.S. and global regulatory strategies for early-stage therapeutic programs (small molecule, peptide, and/or biologics) across a broad range of clinical indications.
• Provide regulatory guidance to cross-functional program teams from preclinical development through early clinical development.
• Design development plans that support global clinical trial initiation (e.g., IND, CTA, IMPD).
• Design regulatory pathways to enable efficient progression from IND to Phase 2 registrational trials.
• Lead regulatory interactions with FDA and other global health authorities (ie FDA, EMA, MHRA, PMDA, Health Canada and other relevant agencies), including pre-IND. meetings, Type B/C meetings, and scientific advice meetings.
• Advise on regulatory risk mitigation strategies and contingency planning.

IND & Submission Management:

• Lead preparation and submission of U.S. INDs and support global regulatory submissions, including Clinical Trial Applications (CTAs), IMPDs, and other regional equivalents.
• Oversee preparation of regulatory documents including:
• Regulatory briefing documents for U.S. and international health authority meetings
• Nonclinical/toxicology summaries
• Clinical protocols
• Investigator Brochures
• Annual reports and safety updates
• Coordinator global submission timelines and ensure consistency across regulatory dossiers
• Ensure high-quality, compliant regulatory documentation aligned with FDA and ICH guidance.

Regulatory Reporting & Compliance:

• Oversee regulatory reporting for:
  
  
  
  • Preclinical and GLP toxicology studies
  • Clinical trials (safety reporting, protocol amendments, annual reports)
  
  
  
  
• Ensure compliance with FDA, ICH, and GCP/GLP standards.
• Maintain regulatory documentation and inspection readiness.

Cross-Functional Collaboration:

• Partner closely with:
  
  
  
  • Nonclinical/toxicology teams
  • Clinical development
  • CMC/manufacturing
  • Quality and compliance
  
  
  
  
• Provide regulatory input into study design to support future registrational pathways.
• Contribute to portfolio-level development strategy and prioritization.

POSITION REQUIREMENTS:

• Advanced degree (PhD, PharmD, MD, or MS) in a relevant scientific discipline.
• Minimum 12+ years of regulatory affairs experience in biotech or pharmaceutical development.
• Demonstrated experience leading successful IND submissions.
• Strong knowledge of U.S. FDA and international regulatory frameworks (EMA, MHRA, PMDA, ICH guidelines)
• Experience with GLP toxicology reporting and regulatory safety submissions.
• Proven experience interacting directly with FDA or other regulatory agencies.
• Ability to operate both strategically and tactically in a fast-moving, translational environment.

Leadership Attributes

• Strategic thinker with the ability to anticipate regulatory challenges.
• Collaborative, team-oriented leader.
• Strong communicator capable of translating regulatory complexity into actionable development strategy.
• Comfortable operating in a lean, innovative environment.

Preferred Qualifications

• Experience supporting programs through Phase 2 or beyond.
• Experience building or scaling regulatory infrastructure.
• Experience contributing to global development plans across multiple therapeutic modalities in multiple indications.
• Prior experience in a global pharmaceutical company or leading cross-regional regulatory teams.

PHYSICAL REQUIREMENTS:

May include: Stationary position for an extended period of time, traverse campus/facility as needed, operate machinery such as computer, phone, copy machine; exposure to cold or hot temperatures.

COMPENSATION:

Calibr-Skaggs offers a unique translational research environment where scientific innovation directly drives therapeutic development. The Director of Regulatory Affairs will have the opportunity to shape regulatory strategy at a foundational stage and meaningfully impact the advancement of novel medicines.