Regulatory Affairs Associate

Regulatory Affairs Associate

Location:

Summit, NJ

The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross‑functional regulatory submission teams. They establish and maintain submission content planners and timelines, facilitate tactical submission meetings, prepare content planners for publishing, interface with publishing vendors, and fulfill Submission Management functions on project teams supporting development, marketing, and post‑marketing regulatory authority applications.

• Manages low to medium impact submission projects to ensure timely delivery of high‑quality dossiers that meet regulatory authorities’ technical specifications.
• Acts as RA submission support to project teams, providing guidance on established submission processes and standards and input to publishing timelines.
• Participates in submission team meetings, expediting, managing, and coordinating multiple concurrent activities for submission projects.
• Coordinates submission publishing with off‑site publishers, ensures resources are available to meet deadlines, prepares content planners, works with vendors to resolve publishing issues, and may perform in‑house publishing tasks.
• Facilitates creation or procurement of submission content deliverables such as cover letters and forms.
• Performs detailed quality reviews of published output to ensure compliance with regulatory standards and health authority guidances—verifying content, bookmarks, hyperlinks, tables of contents—and facilitates team reviews.
• Contributes to development of optimal business processes and standards within the department to ensure high‑quality submissions.
• Contributes to implementation of internal process and standards documents relating to publishing and deliverables.
• Suggests and contributes to process improvements, including changes to software and business processes, and may participate on internal project teams to update business software.
• Demonstrates ability to influence without direct authority while building positive relationships internally and externally.
• Manages own projects with oversight; reviews progress with manager regularly; may assist with onboarding staff.

• Required education:
  Bachelor’s Degree.
• Required experience:
  
  Two years of pharmaceutical or industry‑related experience.
• Preferred experience:
  
  Experience with publishing‑related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/Docu Bridge/Insight platform, Adobe Acrobat).

Seniority Level: Entry level

Employment Type:

Contract

Job Function:
Legal | Industry: Pharmaceutical Manufacturing