Regulatory Affairs Associate

Description

• Position accountability/scope: oSupervision required. Receives project assignments from manager but has responsibility for managing own projects with oversight. Reviews project progress with manager on a regular basis with direction provided by manager. May assist with onboarding staff.
• Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
• Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks
• Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
• Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
• Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team.
• Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
• Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
• Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.

Requirements

• Required Education: Bachelor’s Degree
• Preferred experience: Publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
• Required Experience: Two years pharmaceutical or industry related experience
• Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.

Benefits

• Health Spending Account (HSA)
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Florham Park,NJ. Application Deadline This position is anticipated to close on Jan 7, 2026.
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Medical, dental & vision
• Employee Assistance Program
• Short and long-term disability

Training + Development

Interview process

Visa Sponsorship

Security clearance