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Regulatory Affairs Manager V
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FileImport - Goldbelt Professional Services LLC
Frederick, MD (In Person)
Full-Time
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Job Description
Regulatory Affairs Manager V
OverviewGoldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.
Serve as a subject matter expert in regulatory affairs at the working group-level to informinnovative regulatory approaches to develop MCMs against emerging threats.
Elevate critical programmatic and project level regulatory challenges to the AJPEO MRASregulatory office on critical programmatic and project level regulatory challenges.
Provide training and advisement to DOD staff on regulations, authoring regulatory documents, and interactions with regulatory authoritiesProvide input to Sponsors' regulatory documents for submission to FDA or other NationalRegulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National Regulatory Authority requirements and with the eCTD submission format, as applicable.
Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocolseports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system.
Contribute to the modification, development and implementation of internal policies and procedures.
Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participate in regulatory audits/inspections as required.
Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodiesProvide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.
Create and/or review acquisition and contract documents ((e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
Collaborate and network with internal/external regulatory professionals and clinicians, as well as ...For full information see follow application link. Goldbelt Inc. and its subsidiaries are equal opportunity employers. We recruit, employ, train, compensate, and promote without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.
Summary:
The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.ResponsibilitiesEssential Job Functions:
Serve as a liaison between theAJPEO MRAS
regulatory office and product leads to ensure DoD funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidance.Serve as a subject matter expert in regulatory affairs at the working group-level to informinnovative regulatory approaches to develop MCMs against emerging threats.
Elevate critical programmatic and project level regulatory challenges to the AJPEO MRASregulatory office on critical programmatic and project level regulatory challenges.
Provide training and advisement to DOD staff on regulations, authoring regulatory documents, and interactions with regulatory authoritiesProvide input to Sponsors' regulatory documents for submission to FDA or other NationalRegulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National Regulatory Authority requirements and with the eCTD submission format, as applicable.
Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocolseports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system.
Contribute to the modification, development and implementation of internal policies and procedures.
Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participate in regulatory audits/inspections as required.
Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodiesProvide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.
Create and/or review acquisition and contract documents ((e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
Collaborate and network with internal/external regulatory professionals and clinicians, as well as ...For full information see follow application link. Goldbelt Inc. and its subsidiaries are equal opportunity employers. We recruit, employ, train, compensate, and promote without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.