We are seeking a Regulatory Affairs Publishing Manager to oversee eCTD submission creation and editing, manage publishing deliverables, and ensure regulatory compliance. The candidate will serve as a liaison between stakeholders and vendors, perform quality control on eCTD components, verify regulatory information, and identify and address errors before final submission.
This is a one year contract, 100% Remote (must work EST hours if not on East Coast)
location: Telecommute
job type: Contract
salary: $50.00 - 64.12 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Manage eCTD submissions across product portfolios, coordinating with stakeholders and vendors to ensure timely and compliant submissions to global Health Authorities.
- Oversee publishing deliverables from outsourced vendors, ensuring quality control, proper bookmarking, and regulatory information, while tracking deliverable timelines.
- Act as the primary point of contact for regulatory functions, ensuring smooth handoffs, assessing the impact of agency guidance updates, and driving process improvements.
qualifications:
Required:
- 5+ years of experience in Regulatory Operations, with hands-on management of eCTD submissions across product portfolios, coordinating with stakeholders and vendors to meet submission deadlines.
- Proven experience as a liaison between stakeholders and vendors for the creation, editing, and quality control of eCTD submissions, ensuring regulatory compliance and document accuracy.
- Strong understanding of regulations, with expertise in identifying key eCTD components and in-depth knowledge of U.S. regional regulations for eCTD submissions.
skills: CTD Structure, Regulatory Affairs Operations, Submissions
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
