Regulatory Affairs Operations Specialist

About the role

Kelly Science & Clinical is seeking a Regulatory Affairs Operations Specialist near Bridgewater, NJ. This is a 6 month contract position with a shift of Monday - Friday 8am-5pm and compensation of $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.
• 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.

Benefits

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.