Regulatory Affairs Manager (Mgr Regulatory Compliance 3) 7144 in Fairfax, VA at HII-TSD

Date Posted: 9/25/2022

Job Snapshot

Job Description

Requisition Number: 7144 

Required Travel: 0 - 10%

Employment Type: Full Time/Salaried/Exempt

Hours Per Week: 40 

Security Clearance: Secret 

Level of Experience: Senior 



Who We Are:

HII-Mission Technologies is looking for a Regulatory Affairs Manager to support Joint Project Manager Medical Countermeasures Systems (JPM MCS). **Can work remote.**

HII is a global engineering and defense technologies provider. With a 135-year history of trusted partnerships in advancing U.S. national security, HII delivers critical capabilities ranging from the most powerful and survivable naval ships ever built, to unmanned systems, ISR and AI/ML analytics. HII leads the industry in mission-driven solutions that support and enable a networked, all-domain force. Headquartered in Virginia, HII’s skilled workforce is 44,000 strong.

For a short video about Mission Technologies, click here: https://hii.com/capabilities/mission-technologies/



What You Will Do:

• 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.
• Lead the development and review of regulatory document for submission through the Senior Director Medical Regulatory and the regulatory Sponsor to the FDA or other National Regulatory Authorities (NRAs). 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.
• Draft, manage, maintain and retain regulatory and quality documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in the in accordance with approved business rules in the assigned electronic document management system (such as EDMS). 
• Create and/or review acquisition and contract documents (e.g. Requests for Proposals (RFPs/RPPs), Statement of Work/Performance Work Statements, Acquisition Strategy, Single Acquisition Management Plan (SAMP), Life Cycle Cost Estimates (LCCE)) 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. 
• Contribute to the modification, development and implementation of internal ONE-RAQA policies and procedures for regulatory and quality affairs (such as SOPs)
• Develop and implement regulatory strategies for launching new products and maintaining existing products and provide review, comments and approval of all product claims for technical accuracy and regulatory compliance. 
• Represent the regulatory team, provide regulatory guidance and oversight 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 participates in regulatory audits/inspections as required.
• Plan, prepare and execute for meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies and build rapport with regulators to best position for positive outcome
• Provide 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.  
• Provide regulatory and quality guidance and oversight to other contractors and performers, including identifying and determining which studies require compliance with GxPs and evaluating compliance with those standards and regulatory requirements.
• Conduct quality audits, as assigned for non-clinical, clinical, and manufacturing activities.  Standards are included in FDA regulations, ICH guidelines, ISO documents or other applicable regulatory or quality standards.
• 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.
• Define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts.



What We're Looking For:

  • 8 years relevant progressive experience with Bachelors in related field; 6 years relevant progressive experience with Masters in related field; or High School Diploma or equivalent and 12 years relevant progressive experience.
  • Experience with providing critical review of documentation supporting regulatory applications.
  • Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e.g. FDA regulations, ICH guidelines). Contractor shall have the capability to interpret and apply their regulatory expertise 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).
  • 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.  
  • 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. A tradeoff requirement…the Contractor shall possess expertise in Quality Assurance/Compliance and Auditing for medical product development and marketing. 
  • Mastery of FDA and other relevant regulatory authorities’ requirements for clinical study development and implementation and marketing and post-marketing. Contractor shall have experience applying this expert knowledge to products made available through normal approval processes or emergency use mechanisms.   
  • Capable of maintaining strong interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting.
  • Familiar with the eCTD submission format.
  • Active DoD Secret Clearance



Bonus Points If You Have:

  • Certification in Regulatory Affairs or other certification relevant to medical product development and/or auditing is desired.
  • Standard: Possess a Master’s degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: Possess Bachelor’s or Master’s degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.

HII’s Mission Technologies division develops integrated solutions that enable today’s connected, all-domain force. Capabilities include C5ISR systems and operations; the application of AI and machine learning to battlefield decisions; defensive and offensive cyberspace strategies and EW; unmanned, autonomous systems; LVC solutions; platform modernization; and critical nuclear operations. Together, HII's domain expertise and advanced technologies support mission partners anywhere around the globe. For more information, visit tsd.huntingtoningalls.com.

HII is a global engineering and defense technologies provider. With a 135-year history of trusted partnerships in advancing U.S. national security, HII delivers critical capabilities ranging from the most powerful and survivable naval ships ever built, to unmanned systems, ISR and AI/ML analytics. HII leads the industry in mission-driven solutions that support and enable a networked, all-domain force. Headquartered in Virginia, HII’s skilled workforce is 44,000 strong.

HII is an Equal Opportunity/Vets and Disabled Employer. U.S. Citizenship may be required for certain positions.

Next Steps

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