Overview
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 1 day((s))
Skills
Regulatory Specialist
Job Details
Regulatory Specialist
Location: Hybrid: 2 4 Days Onsite presence required in Leesburg or Tysons, VA (Subject to change)
This is a contract-to-hire position.
Job Description:
Regulatory Affairs Specialist with a strong understanding of FDA regulatory processes for drugs, medical devices, or both. The ideal candidate will serve as a Subject Matter Expert (SME), offering in-depth guidance on the end-to-end regulatory lifecycle, including pre-submission planning, documentation requirements, and final approval processes.
Skills Required:
- Must have experience working in regulatory affairs.
- In-depth knowledge of the FDA submission process, regulatory pathways, and lifecycle from pre-documentation to approval.
- Ability to translate complex regulatory processes into clear guidance for non-regulatory teams.
- Strong understanding of FDA guidance documents, GxPs, and federal health regulatory standards.
- Must possess excellent communication, documentation, and organizational skills.
- Ability to work independently with minimal oversight while aligning with broader company goals.
- Must have a Bachelor's degree in a scientific or health-related field.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.