This contract (until the end of the year) role focuses exclusively on regulatory operations and electronic submissions, supporting the compilation and submission of documents to the FDA using eCTD software. The ideal candidate will be proactive, highly organized, and capable of independently managing submission activities with minimal oversight.
location: Berkeley Heights, New Jersey
job type: Contract
salary: $40 - 45 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Compile, publish, and submit regulatory documents to the FDA using eCTD software (e.g., Omnicia), ensuring compliance with all technical and formatting requirements.
- Build and manage electronic submission packages using the eCTD backbone structure and submit via the ESG portal.
- Serve as the primary point of contact for regulatory submissions during the current team member's maternity leave, ensuring timely and accurate delivery of all submission components.
qualifications:
Required:
- 3+ years of hands-on Regulatory Operations experience, specifically focused on eCTD publishing and FDA submission support (excluding CMC, Labeling, or Strategy roles).
- Proficiency with eCTD publishing tools such as Omnicia, Lorenz, or Extedo, with demonstrated ability to build eCTD backbone structures and compile submission-ready packages.
- Proven track record of completing and submitting FDA regulatory submissions independently, including successful delivery via the ESG portal.
skills: Electronic Common Technical Document (eCTD)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
