We are seeking a Regulatory Affairs Scientist to join our Life Sciences Division. The qualified candidate will provide regulatory support to government and commercial customers, executing multiple tasks and deliverables.
- Prepare and/or review regulatory documents for Investigational New Drug applications (INDs), Investigational Device Exemptions (IDEs), Master Files (MFs), Biologics License Applications (BLAs), and New Drug Applications (NDAs);
- Prepare, compile and/or publish regulatory submissions in accordance with electronic Common Technical Document (eCTD) requirements;
- Collect and review study-specific documentation for protocols, update regulatory database systems, and maintain regulatory files as required;
- Apply regulations and guidelines (e.g., 21 CFR, ICH, FDA guidance documents, etc.) for clinical research, regulatory compliance and quality review of submissions to the FDA.
- 5 years minimum experience in Regulatory Affairs;
- Bachelor’s degree, preferably in a technical discipline;
- Excellent written and oral communication skills, effective time management skills, and strong attention to detail;
- Solid understanding of eCTD processes;
- Working knowledge and understanding of ICH, CFR, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP);
- Must be able to work independently following a brief period of specific technical training.
- Regulatory Affairs Certification (RAC);
- Experience with medical devices;
- Experience with Trial Master Files (TMFs);
- Knowledge of international regulations.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available at https://www.leidos.com/careers/pay-benefits
External Referral Bonus:Eligible
Potential for Telework:Yes, 25%
Clearance Level Required:None
Scheduled Weekly Hours:40
Job Family:Life Scientist
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 38,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.Leidos.com.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.
Securing Your Data
Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to [email protected].
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.