Regulatory Affairs Scientist
Support services will include conducting clinical research studies with experimental medical products under the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP). All of the work to support this research must be performed in accordance with the Federal, Department of Defense (DoD), and Command laws, regulations, and policies. Clinical research studies require production of experimental products, conduct of research studies, laboratory analysis of samples, analysis of resulting data, and submission of study findings.
- The Contractor shall prepare regulatory submissions required for product development and marketing new therapeutic modalities in both domestic and international markets.
- The Contractor shall develop and implement strategies with the goal of approval of regulatory submission and approval, ensuring the overall planning and direction of clinical regulatory activities meets CTC goals.
- Contractor shall apply for all necessary approvals and marketing permits from the FDA as well as other pertinent regulatory offices, and track, obtain and renew any required permits and licenses in a timely manner that complies with product timeline goals.
- Contractor shall provide regulatory guidance, prepare related reports and briefs, as well as review documents for appropriate regulatory scope and language.
Required Knowledge, Skills, and Abilities: Knowledge of clinical research procedures; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels. The candidate should be well-organized; ability to follow detailed instructions; ability to handle multiple tasks; ability to meet deadlines of projects; ability to facilitate communication among supervisors, team members, and peers.
Minimum Education/Training Requirements: PHD in related scientific discipline
Minimum Experience: 2 to 4 years of experience working with human subject research protocols. Superior knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA.