Director Regulatory Affairs


Director Regulatory Affairs


Position         Director Regulatory Affairs          

Company      resTORbio, Inc.        

Location        Boston, MA  



resTORbio, Inc. (NASDAQ: TORC, $482M mkt cap) is a clinical-stage biopharmaceutical company focused on helping people live healthier longer through the development and commercialization of novel therapeutics for the treatment of aging-related diseases. resTORbio’s lead program is targeting the selective inhibition of TORC1 - an evolutionary conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiac and neurologic systems. resTORbio program has demonstrated in several clinical trials, including a randomized, placebo-controlled trial, the potential to treat multiple diseases of aging for which there are no approved therapies. RTB101, resTORbio’s lead drug candidate is a selective, orally administered, TORC1 inhibitor currently being tested in a Phase 2b clinical trial as a first in-class immunotherapy for reducing the incidence of respiratory tract infections in the elderly by enhancing the function of the immune system. The company expects to develop RTB101 for additional aging-related indications such as heart failure or neurodegenerative diseases. 


resTORbio is currently growing its Regulatory team to support global development and is searching for a Director, Regulatory Affairs.  This individual will be responsible for developing regulatory strategies and managing high-quality submissions to regulatory agencies through external consultants.  This position reports to the Vice President, Regulatory Affairs.


  • Collaborate with VP, Regulatory Affairs to define and execute regulatory strategies to ensure product approvals consistent with corporate objectives and applicable regulations and guidelines.
  • Author regulatory documents and lead the preparation of regulatory submissions including meeting briefing packages, INDs, CTAs, annual reports, NDAs, MAAs
  • Coordinate with external publishing resources for on-time delivery of accurate, compliant, and high-quality regulatory submissions to regulatory agencies
  • Lead the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA)
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Establish and maintain postings for supported studies
  • Establish relevant processes and procedures to support the Regulatory Affairs activities
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements


  • Bachelor's degree in life sciences required; advanced degree preferred
  • Minimum of 8 years Regulatory Affairs experience
  • Evidence of successful submissions to FDA/EMA (e.g., INDs, briefing packages)
  • Demonstrated evidence of writing of regulatory documents (Module 1, Module 2, briefing packages, fast track designation applications, etc.)
  • Knowledge of FDA and ICH regulations and guidelines a must
  • Excellent oral and written communications skills as well as the ability to build cross-functional relationships, work collaboratively and influence effectively at all levels cross functionally
  • Ability to work well under pressure and adhere to deadlines
  • Excellent interpersonal skills
  • Strong project management skills and drive for excellence


An attractive compensation package commensurate with this senior leadership role will be provided.



Karen Jauregui
Vice President of Regulatory Affairs

Karen Jauregui brings to resTORbio more than 20 years of global drug development experience including regulatory affairs, clinical operations, quality assurance and project management.  She has worked in many therapeutic areas including anemia, imaging, CNS, GI and osteoarthritis, as well as with pediatric and orphan indications.  She has extensive experience interacting and negotiating with Regulatory Authorities including FDA, EMA and PMDA.  Most recently Karen served as Vice President of Regulatory Strategy at Akebia Therapeutics where she was responsible for global regulatory strategy and planning of early and late stage compounds.  Previously, Karen served as Director of Global Regulatory Affairs at EMD Serono providing regulatory oversight to development programs in various therapeutic areas.   She also served in multiple roles of increasing responsibility at Repligen Corporation including Senior Director of Clinical Operations and Regulatory Affairs.  Karen received her B.S. in Biology and Medical Technology from the State University of New York at Plattsburgh.


Jacob Kind
Senior Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-8828

Zach Spitz
Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1429

Michael Perkel
Associate Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1446

Nicole Brueckman
Research Associate
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1431