Job Title: Regulatory Affairs Manager DTRA/JSTO RA/Quality Assurance Analyst
Posted by: The Tauri Group on Mar 20, 2018
Location:
Fort Belvoir , VA 22060Job Description:
Established in 2001, The Tauri Group is a professional services firm known for our analytic rigor, practical solutions, and trusted advice in the areas of CBRN threat mitigation, defense science and technology, homeland security, and adjacent domains. We offer the financial stability and breadth of capability of a large company coupled with the corporate commitment and attention of a small firm. Our subject matter expertise, determination, agility, and commitment to active and ongoing client and stakeholder engagement enable us to solve tough problems and deliver results-oriented solutions that help our customers achieve mission success. We tackle our clients' most challenging problems by combining analytical rigor with world-class expertise and relevant operational experience. At The Tauri Group, we do what's right for the Program, the Mission, and the Nation.
The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) is the US Department of Defense (DoD) point for research, development, acquisition, fielding and life-cycle support of biological, chemical and nuclear defense equipment and medical countermeasures to the Army, Navy, Air Force, Marine Corps, and Special Operations Command. We are seeking a Regulatory Affairs Manager to assist in organization, planning, assessment and management of regulatory affairs (i.e., FDA) and quality assurance activities. ideal candidate will have experience providing statistical expertise to biotechnology, pharmaceutical drug and/or medical device products.
Candidates must have a current SECRET clearance.
Education and Experience Required
Master's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience. Alternate/Tradeoff Requirement: Bachelor's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience. Desired: regulatory affairs certification. Mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) Medical portfolio. Expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development, as well as previous experience applying this knowledge to the development of a regulatory/quality organization conducting non-clinical and clinical studies and manufacturing development efforts. In addition, be capable of applying this expert knowledge to complex technical problems with minimal supervision. Knowledge of GLP. Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting. Ten (10) years of hands-on experience as a regulatory professional in the pharmaceutical industry or as a contributor/provider of non-clinical and Absorption, Distribution, Metabolism, and Excretion (ADME) (pre-IND enabling) protocols/study reports to the pharmaceutical industry. Experience assessing compounds for further developmental efforts; identifying and ensuring the appropriate IND-enabling studies are conducted; interfacing with the FDA to solicit advice and present developmental results; and authoring, reviewing and approving documents suitable for submission in the Electronic Common Technical Document (eCTD) format. Be capable of maintaining interpersonal contacts within organizations united for the development of medical countermeasures.
Performance Based Taskes Required
Provide expert analysis and advice on the development, management, and improvement of a regulatory organization. Define and document regulatory strategy; provide analysis of candidate maturity; and draft, review, and approve requisite target product profiles of candidates considered promising for advanced development. Advise on, review, and evaluate the presentation of data standards in accordance with current regulatory guidance. Implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities. Define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts. Participate as a regulatory point of contact during product development efforts in order to facilitate cross-communication. In addition, present, orally and in writing, the outcome of these efforts in a timely manner. Present, orally and in writing, the outcome of these efforts in a timely manner. Determine which studies require GLP and provide contract oversight, as well as those studies not requiring GLP yet appropriate quality levels. Participate in medical systems acquisition management activities (e.g., IPT meetings, reviewing acquisition documentation, etc.) and present the outcome, orally and in writing, in a timely manner. Travel for presentations and seminars, and conduct and provide oversight of supplier evaluation visits (e.g., 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 in accordance with audit plans Internal and external current GMP audits in support of the supplier evaluation program to identify and evaluate all risks
In addition, 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.
Assist Headquarters elements in their understanding of the scientific complexity of the research and development efforts and compliance with regulatory and quality regulations surrounding those efforts. Analyze any regulatory issues, providing corresponding risk assessments and guidance on developmental paths forward and presenting/defending these analyses orally and in writing. Apply regulatory analyses based on FDA regulations, regulatory policies, and DoD regulations and guidance across the JPEO-CBD Medical portfolio and present findings, orally and writing. Assess the JPEO-CBD Medical portfolio for sound science and regulatory compliance with FDA regulations and provide assessment and analysis of associated risks, orally and in writing, in a timely manner. Format regulatory submission in the eCTD format. Assist the Risk Manager in risk identification and analysis, as well as development of mitigation plans. 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. Review and assess JPEO-CBD Medical portfolio documents and relevant medical science and technology program documents to assure alignment to advance development efforts (e.g., being able to develop a new drug under FDA rules, and be an advocate for drug development based on FDA rules/regulations, etc.). Attend relevant briefings, presenting the outcome and providing reviews and assessments, orally and in writing, in a timely manner. Assist in the design, development, and implementation of an electronic document management system that will manage (i.e., draft, edit, and approve) documentation, as well as serve as a repository for approved documents with search and retrieve capabilities. Provide expert analysis and advice in all areas of non-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 INDs enabling non-clinical toxicology and ADME studies. Assess need, providing direction and oversight of pilot animal efficacy studies (animal model qualification, challenge materiel, and assays) to obtain human dose correlate. Implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities. Evaluate the workload of developmental efforts, planning and forecasting additional regulatory and quality resources necessary for transitioning products to advanced development. This effort shall include position descriptions and number of full time equivalents required to manage the effort.
At The Tauri Group, you'll collaborate with an elite, creative team of scientists, engineers, analysts, operations specialists, policy experts, and acquisition support specialists. We attract people who love their work and are dedicated to the complex challenges facing today's world. Our culture fosters engagement and enthusiasm, attracts and retains proven experts, and maintains a flexible environment that supports clients and staff. From our easily accessible offices in Alexandria, Virginia to our comprehensive benefits package, every aspect of our operations is designed to bring us the best in the field.
Financially, The Tauri Group is a smart choice, offering:
Highly competitive salaries 401(k), including competitive matching and 100 % vesting after only one year Business development and referral bonuses
We support your life outside of the office, too, with benefits including:
Highly competitive medical insurance and multiple plans to choose from Dental and vision insurance plans Tuition assistance Professional development opportunities Eight paid hours a year that you can devote to charity Flexible work schedules
Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at HR@taurigroup.com
Equal Opportunity Employer, including disabled and veterans.
The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) is the US Department of Defense (DoD) point for research, development, acquisition, fielding and life-cycle support of biological, chemical and nuclear defense equipment and medical countermeasures to the Army, Navy, Air Force, Marine Corps, and Special Operations Command. We are seeking a Regulatory Affairs Manager to assist in organization, planning, assessment and management of regulatory affairs (i.e., FDA) and quality assurance activities. ideal candidate will have experience providing statistical expertise to biotechnology, pharmaceutical drug and/or medical device products.
Candidates must have a current SECRET clearance.
Education and Experience Required
Master's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience. Alternate/Tradeoff Requirement: Bachelor's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience. Desired: regulatory affairs certification. Mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) Medical portfolio. Expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development, as well as previous experience applying this knowledge to the development of a regulatory/quality organization conducting non-clinical and clinical studies and manufacturing development efforts. In addition, be capable of applying this expert knowledge to complex technical problems with minimal supervision. Knowledge of GLP. Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting. Ten (10) years of hands-on experience as a regulatory professional in the pharmaceutical industry or as a contributor/provider of non-clinical and Absorption, Distribution, Metabolism, and Excretion (ADME) (pre-IND enabling) protocols/study reports to the pharmaceutical industry. Experience assessing compounds for further developmental efforts; identifying and ensuring the appropriate IND-enabling studies are conducted; interfacing with the FDA to solicit advice and present developmental results; and authoring, reviewing and approving documents suitable for submission in the Electronic Common Technical Document (eCTD) format. Be capable of maintaining interpersonal contacts within organizations united for the development of medical countermeasures.
Performance Based Taskes Required
Provide expert analysis and advice on the development, management, and improvement of a regulatory organization. Define and document regulatory strategy; provide analysis of candidate maturity; and draft, review, and approve requisite target product profiles of candidates considered promising for advanced development. Advise on, review, and evaluate the presentation of data standards in accordance with current regulatory guidance. Implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities. Define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts. Participate as a regulatory point of contact during product development efforts in order to facilitate cross-communication. In addition, present, orally and in writing, the outcome of these efforts in a timely manner. Present, orally and in writing, the outcome of these efforts in a timely manner. Determine which studies require GLP and provide contract oversight, as well as those studies not requiring GLP yet appropriate quality levels. Participate in medical systems acquisition management activities (e.g., IPT meetings, reviewing acquisition documentation, etc.) and present the outcome, orally and in writing, in a timely manner. Travel for presentations and seminars, and conduct and provide oversight of supplier evaluation visits (e.g., 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 in accordance with audit plans Internal and external current GMP audits in support of the supplier evaluation program to identify and evaluate all risks
In addition, 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.
Assist Headquarters elements in their understanding of the scientific complexity of the research and development efforts and compliance with regulatory and quality regulations surrounding those efforts. Analyze any regulatory issues, providing corresponding risk assessments and guidance on developmental paths forward and presenting/defending these analyses orally and in writing. Apply regulatory analyses based on FDA regulations, regulatory policies, and DoD regulations and guidance across the JPEO-CBD Medical portfolio and present findings, orally and writing. Assess the JPEO-CBD Medical portfolio for sound science and regulatory compliance with FDA regulations and provide assessment and analysis of associated risks, orally and in writing, in a timely manner. Format regulatory submission in the eCTD format. Assist the Risk Manager in risk identification and analysis, as well as development of mitigation plans. 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. Review and assess JPEO-CBD Medical portfolio documents and relevant medical science and technology program documents to assure alignment to advance development efforts (e.g., being able to develop a new drug under FDA rules, and be an advocate for drug development based on FDA rules/regulations, etc.). Attend relevant briefings, presenting the outcome and providing reviews and assessments, orally and in writing, in a timely manner. Assist in the design, development, and implementation of an electronic document management system that will manage (i.e., draft, edit, and approve) documentation, as well as serve as a repository for approved documents with search and retrieve capabilities. Provide expert analysis and advice in all areas of non-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 INDs enabling non-clinical toxicology and ADME studies. Assess need, providing direction and oversight of pilot animal efficacy studies (animal model qualification, challenge materiel, and assays) to obtain human dose correlate. Implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities. Evaluate the workload of developmental efforts, planning and forecasting additional regulatory and quality resources necessary for transitioning products to advanced development. This effort shall include position descriptions and number of full time equivalents required to manage the effort.
At The Tauri Group, you'll collaborate with an elite, creative team of scientists, engineers, analysts, operations specialists, policy experts, and acquisition support specialists. We attract people who love their work and are dedicated to the complex challenges facing today's world. Our culture fosters engagement and enthusiasm, attracts and retains proven experts, and maintains a flexible environment that supports clients and staff. From our easily accessible offices in Alexandria, Virginia to our comprehensive benefits package, every aspect of our operations is designed to bring us the best in the field.
Financially, The Tauri Group is a smart choice, offering:
Highly competitive salaries 401(k), including competitive matching and 100 % vesting after only one year Business development and referral bonuses
We support your life outside of the office, too, with benefits including:
Highly competitive medical insurance and multiple plans to choose from Dental and vision insurance plans Tuition assistance Professional development opportunities Eight paid hours a year that you can devote to charity Flexible work schedules
Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at HR@taurigroup.com
Equal Opportunity Employer, including disabled and veterans.
Pay Rate:
Unspecified
HR. Website URL:
https://taurigroup.com/careers.html#opportunities
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About The Tauri Group,Inc.
The Tauri Group confronts national security challenges by creating innovative, multi-dimensional, and operationally relevant solutions. Decision-makers know they can rely on our expertise and judgment for comprehensive, defensible advice.
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