Regulatory Affairs Manager Level V
Requiring Office: JPM MCS Team: Regulatory Support
Location: Ft. Detrick, MD – On-site
Sub-Title: Regulatory Biostatistician
Responsibilities and Duties
Performance Based Tasks Required
- Provide expert analysis and advice on the development, management, and improvement of a regulatory organization.
- 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.
- Define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts.
- Participate as a regulatory point of contact during product development efforts in order to facilitate cross-communication. In addition, the contractor shall 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.).
- 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
- 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.
- 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-CBD Medical portfolio and present findings, orally and writing.
- Assess the JPEO-CBD 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.
- 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-CBD 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.
- Provide statistical oversight of ongoing clinical and non-clinical studies and manufacturing development (e.g., process validation, sample sizes, stability studies, etc.).
- Develop innovative statistical methods for non-clinical and clinical study protocols to support investigational and marketing applications.
- Propose, develop, evaluate, and verify statistical methodologies performed to support non-clinical and clinical projects (e.g., study designs, sample size calculations, data quality, randomization, etc.).
- Propose, develop, evaluate, and verify statistical methodologies performed to qualify and validate assays, manufacturing processes, and stability studies.
- Review study reports, published literature, and project documents as needed to develop white papers and position papers to support historical perspectives or present and support innovative statistical methodologies.
- Provide statistical training for non-statistical groups.
- Educate and advise non-statisticians (e.g., project management, clinicians, scientists, etc.) on statistical methodologies and approaches, analytical issues to findings, and the process to identify and discuss risks.
- Participate as the statistical subject matter expert during IPT meetings, providing guidance to scientific and non-scientific personnel on the planning of clinical and non-clinical studies.
- Participate as the statistical subject matter expert during official and unofficial meetings with regulatory agencies (e.g., FDA, etc.) and be capable of defending the proposed statistical plan.
- Develop Statistical Analysis Plans (SAPs) for studies to support approval of new drugs, biologics, and/or medical devices.
- Analyze data and study reports and provide statistical interpretations for regulatory submissions (e.g., integrated summary of safety and integrated summary of efficacy submissions, etc.).
Qualifications and Skills
- Master’s degree in Engineering, Science, Business Management, Systems Management, or a related discipline
- 15 years of general experience and 10 years of relevant experience.
- Alternate/Tradeoff Requirement: 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.
- Regulatory affairs certification (Desired)
- A mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) Medical portfolio.
- 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.
- Be capable of applying this expert knowledge to complex technical problems with minimal supervision.
- Possess knowledge of GLP.
- Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting.
- 1 year of experience providing input to FDA submissions and/or developing statistical plans supporting non-clinical and clinical plans.
- Provide statistical expertise in early and/or advanced development of biotechnology, pharmaceutical drug, and/or medical device products.
- Possess experience working in a regulated industry environment (GMP, GCP, and/or GLP), as well as an understanding of FDA regulations and ICH guidance.
- Possess experience in complying with statistical aspects implied in the Animal Rule, assay, manufacturing validation, and/or stability studies.