The Leidos Health Products and Solutions Operation is seeking a Regulatory Affairs Scientist for our Life Sciences Division. This position is located in our Fredrick, MD office.
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 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. The Regulatory Affairs Scientist may collaborate with US and International regulatory colleagues and provide support in the preparation of regulatory documentation.
EDUCATION: Bachelor’s Degree in biological, chemical, pharmaceutical, or related sciences and 2 – 4 years of regulatory experience.
REQUIRED SKILLS: This position requires 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.
DESIRED SKILLS: 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.