Easter Seals Jobs

Description

Unleash Your Potential

At Leidos, we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customers’ success. We empower our teams, contribute to our communities, and operate sustainable. Everything we do is built on a commitment to do the right thing for our customers, our people, and our community. Our Mission, Vision, and Values (https://www.leidos.com/company/mission-vision-and-values) guide the way we do business.

Your greatest work is ahead!

Leidos is seeking a Regulatory Affairs Scientist to join our Performance and Readiness division. The qualified candidate will provide regulatory support to government and commercial customers, executing multiple tasks and deliverables.

Our Leidos team provides critical regulatory guidance at every step of the product development process. We work with client integrated product teams to help them navigate the complex regulatory pathway from research and development to clinical trials and licensure. Leidos provides comprehensive regulatory affairs consulting services to foster the submission and approval of accurate, scientifically sound regulatory documents.

This is a 100% REMOTE position.

Candidate must be a US Citizen – Sponsorship is not available for this position.

Why Leidos?

Pay and benefits are fundamental to any career. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include attractive compensation, health and wellness programs, flexible leave, and retirement plan. More details are available at https://www.leidos.com/careers/pay-benefits

What you will do:

• Prepare and/or review regulatory documents for Investigational New Drug applications (INDs), Investigational Device Exemptions (IDEs), Master Files (MFs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Investigational Device Exemptions, 510(k)s, and Combination Products.

• Review, comment, and advise customer on content of Investigator Brochures, product support plans, temperature excursions, stability tables, and Certificate of Analysis (CoA).

• Prepare, compile, and/or publish regulatory submissions in accordance with electronic Common Technical Document (eCTD) requirements with specific experience writing and evaluating Module 2 and 3.

• Collect and review study-specific documentation for protocols, update regulatory database systems, and maintain regulatory files as necessary, with a particular focus on Chemistry, Manufacturing and Controls.

• Manage small regulatory projects in accordance with contract language.

• 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.

Qualified candidates will have:

• 5 years minimum experience in Regulatory Affairs

• Bachelor’s degree, preferably in chemistry or other life science.

• U.S. citizenship.

• Excellent written and oral communication skills, effective time management skills, and strong attention to detail.

• Solid working knowledge of eCTD submission processes and regulatory management systems like Veeva Vault.

• Working knowledge and comprehension of International Council for Harmonisation (ICH), Code for Federal Regulations (CFR), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).

• Must be able to work independently following a brief period of specific technical training.

You will stand out with:

• Regulatory Affairs Certification (RAC).

• Familiarity with medical device and/or combination products regulations.

• Project Management experience (2-3 years).

• Experience with electronic Trial Master Files (eTMFs).

• Familiarity with international regulations.

Original Posting Date:

2024-07-10

While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.

Pay Range:

Pay Range $81,250.00 - $146,875.00

The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

#Remote

REQNUMBER: R-00138970

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.