The Life Sciences Division at Leidos currently has an opening for a Regulatory Affairs Scientist to work in our Frederick, MD office. This is an exciting opportunity to use your experience to assist our clients submit regulatory filings to the U.S. Food and Drug Administration (FDA) for medical products to treat infectious diseases.
The Regulatory Affairs Scientist is responsible for 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 FDA. The incumbent will collect and review documentation for clinical trial protocols, update regulatory database systems and maintain electronic 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. The Regulatory Affairs Scientist may collaborate with US and International regulatory colleagues and provide support in the preparation of regulatory documentation.
This position requires a Bachelor's Degree in biological, chemical, pharmaceutical, or related sciences and 2 - 4 years of regulatory experience. The incumbent should have a solid 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, excellent written/verbal communication skills in addition to strong interpersonal skills. This position requires exceptional 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.
Customer-focused regulatory work in the pharmaceutical industry and prior experience serving U.S. government clients is a plus. Regulatory Affairs Certification is also highly desired.