Regulatory Affairs Manager Level V
Venesco, LLC – Fort Belvoir, VA
Regulatory Affairs Manager Level V
JPM MCS Team: Regulatory Support
Fort Belvoir, VA
Position Sub-Title: DTRA/JSTO RA/Quality Assurance Analyst
Responsibilities and Duties
- 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.).
Qualifications and Skills
- Master’s degree in Engineering, Science, Business Management, Systems Management, or a related discipline
- 15 years of general experience and ten (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.
- Desired: A regulatory affairs certification.
- Possess and maintain 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.
- 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, the contractor shall 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.
- 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.
- The contractor shall be capable of maintaining interpersonal contacts within organizations united for the development of medical countermeasures.