Job Postings

Director Regulatory Affairs

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Director Regulatory Affairs


POSITION DESCRIPTION

Position         Director Regulatory Affairs          

Company      resTORbio, Inc.        

Location        Boston, MA  

Website         https://www.restorbio.com/


COMPANY BACKGROUND

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. 


ROLE: DIRECTOR REGULATORY AFFAIRS

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.


KEY RESPONSIBILITIES

  • 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 ClinicalTrials.gov 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

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • 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

COMPENSATION

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


HIRING EXECUTIVE PROFILE

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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.


TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE

Jacob Kind
Senior Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-8828
Email: jkind@kleinhersh.com

Zach Spitz
Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1429
Email: zspitz@kleinhersh.com

Michael Perkel
Associate Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1446
Email: mperkel@kleinhersh.com

Nicole Brueckman
Research Associate
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1431
Email: nbrueckman@kleinhersh.com


Senior CMC Specialist

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Senior CMC Specialist


POSITION DESCRIPTION

Position           Senior CMC Specialist
Company        resTORbio, Inc.
Location         Cambridge, MA
Website           https://www.restorbio.com/


COMPANY BACKGROUND

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.


KEY RESPONSIBILITIES

  • Participation in outsourced API and DP manufacturing processes
  • Participation in solving potential manufacturing processes challenges
  • Participation in oversight of manufacture of regulatory starting materials, intermediates and API in support of clinical trial material requirements and commercial process validation
  • Participation in ensuring that regulatory starting materials and API process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively co-overseeing process development and manufacturing campaigns
  • Participation in ensuring that DP process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively co-overseeing process development and manufacturing campaigns
  • Review API and DP batch records, analytical methods validation plans, process validation plans and protocols, manufacturing campaign reports.
  • Contribute to CMC regulatory submission as a subject matter expert
  • Prepare technical reports, patent application content, publications and oral presentations as necessary
  • Communicate progress and strategy in various forums including reports, presentations and open discussions

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • PhD in synthetic organic chemistry and or DP formulation development or Pharmacy degree and least 5 years’ experience in pharmaceutical industry or similar M.S. degree with at least 8 years of experience
  • In-depth knowledge of medicinal/synthetic organic chemistry, chemical process development,
  • DP formulation process development and efficient process throughput concept
  • Experience working in a virtual model setting is a plus
  • Proven track record of successfully overseeing API chemistry program and DP process development
  • Experience working with analytical and formulation development, quality assurance and control teams
  • Experience with contributing to CMC sections of clinical trial and marketing applications worldwide
  • Excellent interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced environment and able to adjust based upon changing priorities

HIRING EXECUTIVE PROFILE

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Abdellah Sentissi
Head of CMC

Dr. Sentissi joined resTORbio as Head of CMC and Pharmaceutical Development in January 2017. Dr. Sentissi brings more than 30 years of experience leading manufacturing and quality functions for biotechnology companies. During his career working with several companies as a consultant or as functional leader, Dr. Sentissi led several products through scale-up, registration and validation runs, facility validation and all related quality assurance and control functions. Dr. Sentissi earned his Pharmacy degree from the School of Medicine and Pharmacy-University Paul Sabatier, Toulouse, France and a Ph.D. in Biomedical Sciences from Northeastern University. He also holds multiple French National Certifications in Medical Pathology, Immunology, Hematology and Parasitology from the School of Medicine and Pharmacy-University Paul Sabatier and the School of Pharmacy of Montpellier, France.

https://www.linkedin.com/in/abdellah-sentissi-43ba718/


TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE

Jared Kaleck
Client Partner
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-9229
Email: jkaleck@kleinhersh.com


Marc Miller
Client Partner
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-0294
Email: mmiller@kleinhersh.com


Nicole Brueckman
Research Associate
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1431
Email: nbrueckman@kleinhersh.com