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Regulatory Affairs Specialist
Join the HJF Team!
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
This position will be in support of the Laboratory of Antigen and Adjuvant Research (LAAR) within the U.S. Military HIV Research Program (MHRP) located at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD.
HJF is seeking a Regulatory Affairs Specialist to assist with day-to-day operations, management and oversight in order to maximize the effective use of project resources. Specific areas include: CBER, FDA-related regulatory document management, animal studies management, and laboratory operations management. Collaborates across multidisciplinary programs for preclinical and clinical studies. Assists Section Chief with organization and tracking of correspondence and ensures and facilitates execution to completion and update of requirements.
- Prepares, updates and reviews Investigation New Drug (IND) applications, Drug Master Files, pre-IND, Product Stability Programs, Pharmacy Mixing Protocols, short-term mixing and stability programs for Regulatory Sponsor submission to the CBER, FDA. Emphasis is on Chemistry, Manufacturing and Control (CMC) and pre-clinical sections of FDA regulatory documents.
- Facilitates regulatory information flow between LAAR, collaborating PIs (government and private), contract entities, HJF and US Army. Coordinates the regulatory decision-making process between all multidisciplinary program participants to ensure operational objectives are being met. Demonstrates diplomacy when interacting with all internal and external staff.
- Identifies and evaluates regulatory problems pertaining to adjuvant formulations and vaccine formulations. Provides solutions in a timely manner. Resolves problems and exercises judgment within generally defined practices, policies, and guidelines.
- Leads and works closely with Section Chief to develop assays, which will analyze vaccine adjuvants and formulations and supports regulatory submissions.
- Attend regulatory affairs meetings and scientific meetings in order to remain current on regulatory statutes and practices and maintain scientific expertise.
- Works with cGMP staff, section scientists and contractors to develop Batch Production Records, Release Testing Criteria and Product Stability Plans.
- Oversees all Standard Operating Procedures (SOPs) laboratory protocols, and other reports needed as directed by Section Chiefs.
- Oversees and coordinates the scheduling of section animal studies.
- Assists in the preparation of manuscripts, grant applications and reports.
Required Knowledge, Skills and Abilities
- Ability to use sound judgment in solving problems
- Knowledge of organizational objectives, regulatory drug approval process, FDA regulatory document filings, particularly IND CMC section fillings, technology transfer process, and office automation.
- Proficiency in writing scientific and regulatory documentation.
- Excellent communication and writing skills, interpersonal and organizational skills.
- Ability to coordinate many complex systems and programs at the same time.
- Must be a self-starter, able to work independently, and able to multi-task.
- Capacity to solve difficulties using sound judgment.
- Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, cloud-based eRegulatory platforms, and E-mail.
- This position will take place primarily in an office setting.
Education and Experience
- Bachelor’s Degree is required.
Senior Regulatory Affairs Specialist:6-8 years of relevant work experience required. Experience with CBER, FDA submissions is not required, but strongly desired.
Regulatory Affairs Specialist:Minimum: of 3-5 years of experience required.Regulatory Affairs Specialist: 3-5 years related experience in scientific project or program management. Experience with CBER, FDA submissions is not required, but strongly desired
Licenses and Certifications
- Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.
All HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
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)
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
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Job posted: 2022-09-05