The Life Sciences Division at Leidos currently has an opening for a Senior 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 Senior Regulatory Affairs Scientist will manage the preparation of large regulatory projects, facilitating the efforts of multiple technical areas to include product development experts, medical writers, and document specialists, in the creation and assembly of submission-ready Investigation New Drug (IND), pre-IND, Master File, Investigational Device Exemption (IDE), and 510(k)/premarket approval regulatory filings. 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 Sr. 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 8 - 12 years of regulatory experience or a Master's Degree with 6 - 10 years of experience. The incumbent should have an advanced level of 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 should have experience developing nonclinical/clinical protocols, submitting regulatory filings to the FDA and developing solutions to complex regulatory affairs issues. The incumbent 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. The individual will manage communications with internal and client team members across multiple areas of discipline.
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.