LMI Government Consulting
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Regulatory Affairs Manager V
at LMI Government Consulting
- Job ID
- # of Openings
- Consulting/Business Management
LMI is seeking a Regulatory Affairs Manager V to oversee the regulation process for products requiring governmental approval, including a mastery of medical product regulations such as FDA regulations, inferences, and regulatory requirements, and the capability to interpret and apply them
- Provide regulatory advice, management and oversight total lifecycle management of the product from early product development through interim fielding (emergency use regulatory mechanisms) to approval, clearance or licensure and throughout post marketing as appropriate.
- Support and or execute regulatory program management, developing and reviewing regulatory documents (Target Product Profile, Regulatory Strategies, Regulatory White Papers, regulatory briefings, etc.) including executing and overseeing development of documents for other internal and external regulatory agencies as needed
- Lead the development and review of regulatory document for submission to FDA or other National Regulatory Authorities (NRAs).
- Create and/or review acquisition and contract documents 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.
- Read, review and provide comments in the evaluation of non-clinical, clinical, and manufacturing documentation to ensure appropriateness, accuracy, and applicability to appropriate regulatory guidance.
- Regulatory team member to the IPT and provide regulatory guidance and oversight on regulatory and quality matters during the development process.
- Provide regulatory advice to ensure all programs are on track with good pharmaceutical development, manufacturing, and clinical practices (cGxPs).
- Conduct quality audits and oversight in the realm of non-clinical, clinical, and manufacturing activities. Standards are included in FDA regulations, ICH guidelines, ISO documents or other applicable regulatory or quality standards.
- Provide regulatory expertise in other areas affecting the development process (e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).
- Provide regulatory input into the evaluation of candidate technologies throughout the product development lifecycle to determine the appropriate technology/manufacturing readiness level, foster timely pharmaceutical based decision making and ensure efficient and appropriate transitions through the regulatory and advanced development stages.
- Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.
- Capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self- starting
Preferred Requirement: Master’s degree in Engineering, Science, Medical, Nursing, Veterinary, Business Management, Systems Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
Minimum Requirement: Bachelor’s degree in Engineering, Science, Medical, Nursing, Veterinary Business Management, Systems Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
- Preferred: Regulatory affairs certification is desired and will be at no cost to the Government.
- Possess and maintain a mastery of medical product regulations such as FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to the Joint Program Executive Office for Chemical, Biological, Radiological, Nuclear Defense (CBRND) and Defense Threat Reduction Agency Joint Science and Technology Office (DTRA-JSTO).The contractor shall possess a mastery of current commercial advanced pharmaceutical development and associated intellectual property management best practices, and maintain currency thereof.
- Understand medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity, and other non-clinical and clinical research and development standards, requirements and considerations.
- Have mastery of cGxPs (cGLP, cGMP, cGCP, etc.) and expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development and experience applying this expert knowledge to complex technical problems with minimal supervision.