Regulatory Affairs Manager

2 months ago
Company
Noblis-ESI
Requisition #
5692
Security Clearance
Secret
FT/PT/On-Call
Full Time
Job Category
Biology and Chemistry
Location
US-VA-Alexandria

Responsibilities

  • The candidate shall provide expert analysis and advice in all areas non-clinical/clinical that support the development of basic research candidates into advanced development. This includes non-clinical studies to aid in the down select of potential candidates and development/oversight of IND enabling non-clinical toxicology and ADME studies.  Where required, the candidate will assess need, provide direction and oversight of pilot animal efficacy studies (animal model qualification, challenge materiel and assays) to obtain human dose correlate.  Contractor will be knowledgeable in GLP to determine which studies require GLP and provide contract oversight as well as those studies not requiring GLP yet appropriate quality levels.
  • The candidate shall be able to define/document regulatory strategy, provide analysis of candidate maturity and draft/review/approve requisite target product profiles of product candidates considered promising for advanced development.
  • The candidate will be required to travel for presentations, seminars as well as conduct/provide oversight of supplier evaluation visits (due diligence, mock audits, vendor qualifications, etc.). This will include the following:
    • Inspection of contract laboratories or other facilities providing data in support of GLP studies to assure compliance with GLP guidelines, applicable protocols, and SOPs
    • Periodic facility audits of facilities, equipment, and records required by GLPs
    • QMS audits of ISO/FDA elements related to the control of documents and data
    • Regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections
    • GCP training and the development and maintenance of GCP-related quality systems
    • GCP compliance audits of investigator sites, CRO facilities, and vendors, including clinical sample labs IAW audit plans
    • Internal and external cGMP audits in support of the supplier evaluation program to identify and evaluate all risks

In addition, the candidate shall provide expert analysis and advice in the follow-up actions (e.g., formal reports, updates of related databases, etc.) of these audits and inspections.

  • The candidate shall provide expert analysis and advice on the development, management and improvement of a regulatory organization, implement quality systems and procedures to ensure compliance with all applicable laws, regulations and organizational quality standards in support of advanced development activities. The candidate will assist in the design, development and implementation of an electronic document management system that will manage (draft/edit and approve) documentation as well as serve as a repository for approved documents with search and retrieve capabilities.  
  • The candidate will evaluate the development efforts workload and plan/forecast additional regulatory and quality resources necessary for transitioning products to advanced development. Effort shall include position descriptions and number of FTEs required to manage the effort.
  • The candidate will define/draft and implement the regulatory and quality infrastructure necessary to support all research development efforts.
  • The candidate will assist the Risk Manager in risk identification and analysis, as well as development of mitigation plans.
  • The candidate will plan (i.e., develop meeting agendas), participate in, and provide support (i.e., develop meeting minutes and track action items) to the RA/QA working group.
  • The candidate will assist Headquarters elements in their understanding of the scientific complexity of the research development efforts and compliance with regulatory and quality regulations surrounding those efforts as required.
  • The candidate will possess a sound understanding of the pharmaceutical development lifecycle to develop regulatory strategy and to ensure the development pipeline aligns with advanced development requirements for sustainability
  • The candidate will have an in depth understanding of novel regulatory pathways to support medical countermeasure licensure submissions
  • The candidate should be able to evaluate product development business models and be comfortable providing feedback to senior level personnel

Qualifications

  • Please note:  This role will require a US Security clearance at least at the Secret level, or higher.

 

  • Education: Advanced degree in Biological Sciences, Engineering, Business Management, Systems Management, or a related discipline, as well as more than 10 years of hands on experience as a Regulatory Professional in the pharmaceutical industry or as a contributor/provider of non-clinical and ADME (Pre-IND Enabling) protocols/study reports to the pharmaceutical industry and 2 years of hands on experience as a Regulatory Professional. 
  • RA Certification preferred but not a requirement. 
  • Desired: The candidate shall possess expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical and biologics development. 
  • Previous experience applying this knowledge to the development of a regulatory/quality organization conducting nonclinical and clinical studies as well as manufacturing development efforts. 
  • Demonstrated capabiblity of applying this expert knowledge to complex technical problems with minimal supervision. 
  • Experience in assessing compounds for further development efforts, identifying and ensuring the appropriate IND-enabling studies are conducted, interfacing with the FDA to solicit advise/present development results and author/review and approve documents suitable for submission in the eCTD format. 
  • Must be self-starter, maintain interpersonal contacts to increase effective team dynamics and be able to effectively communicate ideas, requirements and scientific knowledge across and within organizations united for the development of medical countermeasures. The candidate should also have experience interfacing with senior personnel at regulatory and other government agencies.

 

Position is located at Ft. Belvoir, VA

Overview

Noblis and our wholly owned subsidiaries, Noblis ESI and Noblis NSP, are solving difficult problems that help our government and our country. We bring the best of scientific thought, management, and engineering expertise with a reputation for independence and objectivity. We support a wide range of government and industry clients in the areas of national security, intelligence, transportation, healthcare, environmental sustainability, and enterprise engineering. Learn more at noblis.org/about.

 

Why work at a Noblis company?

Our employees find greater meaning in their work and balance the other things in life that matter to them. Our people are our greatest asset. They are exceptionally skilled, knowledgeable, team-oriented, and mission-driven individuals who want to do work that matters and benefits the public.

 

Noblis has won numerous workplace awards. Noblis maintains a drug-free workplace and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race.

 

About the Work:

The candidate shall support the Joint Program Executive Office for Chemical And Biological Defense (JPEO-CBD) and the Joint Project Management Offices (JPMOs) which report directly to the JPEO-CBD. Noblis ESI is seeking a qualified Regulatory Affairs Manager for support to the Joint Program Executive Office (JPEO) contract specifically the Medical Domain to assist in the organization, planning, assessment, and management of regulatory affairs (i.e., FDA) and quality assurance activities to support the research, development, and acquisition of JPEO-CBD medical systems.

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