Regulatory Affairs Manager V (7884)

05 Sep, 2022

Jobs

Regulatory Affairs Manager V (7884)

Patricio Enterprises
Stafford, VA

DESCRIPTION: Patricio Enterprises is actively searching for a Regulatory Affairs Manager V to support Joint Project Manager Medical Countermeasures Systems (JPM MCS) team.

Primary duties will include (but not limited to):

  • 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.
  • 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.
  • 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,  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.
  • Assess the JPEO-CBRND 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-CBRND 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.
  • 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.

KNOWLEDGE AND SKILLS:

  • Possess 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.
  • Possess knowledge of GLP.
  • 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-CBRND Medical portfolio and present findings, orally and writing.
  • Define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts.

 EDUCATION / EXPERIENCE:

  • Standard Requirement: Possess a 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.
  • Tradeoff Requirement: Possess 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.
  • Preferred: Regulatory affairs certification is desired and will be at no cost to the Government.
  • Possess and maintain a mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to the JPEO-CBRND Medical portfolio.
  • Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting.
  • Possess 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.
  • Possess 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.
  • Provide expert analysis and advice on the development, management, and improvement of a regulatory organization.
  • 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.

 

Patricio Enterprises is a federal contractor subject to the Executive Order on Ensuring Adequate Covid Safety Protocols for Federal Contractors requiring all employees to be fully vaccinated.

By applying for this position, you acknowledge that you will be required to provide proof that you are fully vaccinated upon hire, or to verify that you cannot be vaccinated due to a legally recognized exception to the vaccine mandate set forth in the Executive Order.

Note: An individual is not considered to be fully vaccinated until two weeks after receiving the last vaccine dosage in a vaccine regimen, either single shot or multiple vaccine cycle.

EOE. Protected Veterans/Individuals with Disabilities.
Patricio Enterprises Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Learn more here

Job posted: 2022-09-05