Job Title: JE-OPETS Regulatory Affairs Manager
Posted by: The Tauri Group on Mar 20, 2018
Location:
Frederick , MD 21702Job 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 support the JPEO CBD Joint Project Manager for Medical Countermeasure Systems under the upcoming JE-OPETS contract. The successful candidate will 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.
Candidates must have a current SECRET clearance.
Education and Experience Required
Masters Degree in Engineering/Science/Business with 8 years general experience and 5 years relevant experience or a Bachelors Degree in Engineering/Science/Business with 10 years general experience and 7 years relevant experience
Experience with the DoD acquisition system as it relates to the development of medical products/devices; DAU certification desirable
Experience with the FDA drug development process
Expertise in working with regulatory documentation within the DoD
Experience developing and providing regulatory strategies to government programs and interacting with agency personnel
Responsibilities
Supports the Department of Defense in managing the Regulatory Program, executing and overseeing development of medical products, inclusive of DoD, FDA, EPA and CDC regulations.
Creates/reviews DoD acquisition documents to ensure regulatory/quality requirements are appropriate and consistent with FDA regulations, and provides additional regulatory expertise as needed to ensure DoD programs are on track with good pharmaceutical development and manufacturing practices.
Evaluates DoD acquisition documents that have FDA regulatory requirements or impact the drug development timeline.
Provides regulatory expertise on other areas affecting development process such as contracting efforts (e.g. RFPs, SSEBs, etc.).
Evaluates new technology for transitioning to Advanced Development, and identifies appropriate technology/manufacturing readiness levels.
Develops regulatory strategy.
Advises on regulatory and quality matters during the development process.
Evaluates nonclinical, clinical and manufacturing documentation to ensure appropriateness, accuracy and applicability to appropriate regulatory submissions.
Collaborates and networks with internal/external Regulatory Professionals; internal/external clinicians, investigators and researchers to maintain current and knowledgeable presence in CBRN development areas.
Conducts regulatory quality audits in the realm of nonclinical, clinical and manufacturing activities.
Provides coordination and staff support for regulatory, pharmaceutical, and portfolio integration chiefs.
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 support the JPEO CBD Joint Project Manager for Medical Countermeasure Systems under the upcoming JE-OPETS contract. The successful candidate will 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.
Candidates must have a current SECRET clearance.
Education and Experience Required
Masters Degree in Engineering/Science/Business with 8 years general experience and 5 years relevant experience or a Bachelors Degree in Engineering/Science/Business with 10 years general experience and 7 years relevant experience
Experience with the DoD acquisition system as it relates to the development of medical products/devices; DAU certification desirable
Experience with the FDA drug development process
Expertise in working with regulatory documentation within the DoD
Experience developing and providing regulatory strategies to government programs and interacting with agency personnel
Responsibilities
Supports the Department of Defense in managing the Regulatory Program, executing and overseeing development of medical products, inclusive of DoD, FDA, EPA and CDC regulations.
Creates/reviews DoD acquisition documents to ensure regulatory/quality requirements are appropriate and consistent with FDA regulations, and provides additional regulatory expertise as needed to ensure DoD programs are on track with good pharmaceutical development and manufacturing practices.
Evaluates DoD acquisition documents that have FDA regulatory requirements or impact the drug development timeline.
Provides regulatory expertise on other areas affecting development process such as contracting efforts (e.g. RFPs, SSEBs, etc.).
Evaluates new technology for transitioning to Advanced Development, and identifies appropriate technology/manufacturing readiness levels.
Develops regulatory strategy.
Advises on regulatory and quality matters during the development process.
Evaluates nonclinical, clinical and manufacturing documentation to ensure appropriateness, accuracy and applicability to appropriate regulatory submissions.
Collaborates and networks with internal/external Regulatory Professionals; internal/external clinicians, investigators and researchers to maintain current and knowledgeable presence in CBRN development areas.
Conducts regulatory quality audits in the realm of nonclinical, clinical and manufacturing activities.
Provides coordination and staff support for regulatory, pharmaceutical, and portfolio integration chiefs.
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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