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Regulatory Affairs Operations Specialist at Kelly
Kelly
No longer available
$50 - $60/hour
Finance
Posted 16 hours ago
JOB DESCRIPTION
Regulatory Affairs Operations Specialist
Kelly Science & Clinical is seeking a Regulatory Affairs Operations Specialist near Bridgewater, NJ.
6 month contract position
Shift: Monday Friday 8am-5pm
Compensation: $50-$60/hr DOE
Responsibilities:
- Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health Authorities including the US FDA and Health Canada.
- Responsible for preparing, dispatching and archiving 2253 submissions for OPDP.
- Communicating with RA Strategy and/or CMC Leads to ensure content accuracy and identify issues that could be incompliant with health authority guidance or impact compliance timelines.
- Ensuring final documents are submission-ready and compliant with applicable health authority requirements while addressing any advanced document or technical issues as needed.
- Archiving regulatory submissions and related correspondence in accordance with established archiving and document retention strategies and maintaining accurate records in RIM systems.
- Assisting in development and maintenance of Regulatory Operations best practices and contributing to process improvements to enhance efficiency and quality.
- Performing other responsibilities as assigned.
Qualifications:
- Experienced technical skills for the preparation, publishing, and archiving of regulatory documents including tracking the status in RIM systems such as Veeva RIM.
- Knowledgeable about the FDA and Health Canada eCTD submissions lifecycle management, as well as the associated guidance, specifications, and regulations.
- Proficient in eCTD format and regulatory submission requirements.
- Working knowledge of document management systems and regulatory publishing tools, preferably with Veeva RIM and docuBridge.
- Ability to balance multiple tasks while meeting priorities and timelines.
- Experienced in leading the management of submissions and timelines and collaborating with team members.
- Demonstrate strong communication skills and the ability to work effectively within a team.
- A minimum of 3 years of combined pharmaceutical and regulatory experience.
- Bachelor's degree preferred.