Regulatory Affairs Associate
The Regulatory Affairs Associate is responsible for supporting the Regulatory Affairs Scientist during the review and preparation of information for Investigational New Drug (IND), Investigational Device Exemption (IDE), Master Files, Annual Reports and regulatory amendments required to be submitted to the U.S. Food and Drug Administration (FDA). The incumbent will be responsible for collection and review of study specific documentation for protocols, update of regulatory database systems and maintenance of hard copy regulatory files. The candidate should be proficient with constructing, compiling, reviewing and maintaining regulatory submissions in accordance with electronic Common Technical Document (eCTD) requirements and performing as a team member supporting various government and commercial customers.
EDUCATION: Bachelor’s Degree in biological, chemical, pharmaceutical, or related sciences and 0 – 2 years of regulatory experience.
REQUIRED SKILLS: This position requires a basic understanding of Good Laboratory/Clinical/Manufacturing Practice (GLP, GCP, and cGMP), International Committee on Harmonization (ICH) guidelines, FDA regulations and guidance documents, and quality assurance procedures. The individual must demonstrate a high level of attention to detail and accuracy, good written/verbal communication skills in addition to interpersonal skills. This position requires organizational and documentation skills, proficiency in the MS Office suite of products, Adobe Acrobat, and experience in document management and collaboration (document sharing) systems and regulatory databases.
DESIRED SKILLS: Customer-focused regulatory work in the pharmaceutical industry and prior experience serving U.S. government clients is a plus.
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.