Job Description

Pay Range $34.00/hr - $38.00/hr Location: Florham Park, NJ 07932 (100% Onsite) Duration: 12-Month Contract (Extension Based on Performance & Budget) Shift: Monday - Friday Contact: siddhi.kadakia@collabera.com (No C2C/Vendors) Position Details Industry: Pharmaceutical Job Title: Regulatory Affairs Associate I - Submission Management Pay Range: $34.00 to $35.00 per hour Purpose The Regulatory Affairs Associate I - Submission Management supports regulatory submission activities by managing low- to medium-impact regulatory submission projects. This role is responsible for coordinating submission content, maintaining submission timelines, supporting publishing activities, and ensuring submissions meet regulatory authority technical and quality standards. The position works cross-functionally with Regulatory Affairs, Development, Marketing, and post‑marketing teams to support global regulatory applications. Experience & Education Bachelor’s Degree required Minimum of 2 years of pharmaceutical or industry‑related experience Higher education may compensate for years of experience Years of experience may compensate for lower education Required Experience 2+ years of experience in the pharmaceutical or related regulated industry Experience supporting regulatory submission activities Experience coordinating cross‑functional teams and timelines Ability to manage multiple concurrent submission projects Familiarity with regulatory submission standards and health authority requirements Experience performing quality reviews of regulatory documents Preferred Experience Experience with publishing‑related software tools, including Documentum eCTDXPress / ISI Publisher ISI Toolbox DocuBridge / Insight Platform Adobe Acrobat Experience interfacing with submission publishing vendors Experience supporting eCTD submissions Responsibilities Manage low- to medium‑impact regulatory submission projects to ensure timely delivery of high‑quality dossiers. Establish, maintain, and track submission content planners and associated timelines. Act as Regulatory Affairs Submissions support to project teams by guiding submission processes and standards. Participate in and facilitate submission team meetings. Coordinate and manage multiple interrelated submission activities concurrently. Anticipate submission risks and propose solutions to meet timelines. Prepare content planners for publishing and coordinate submission publishing with off‑site vendors. Interface with publishing vendors to resolve publishing issues; may perform limited in‑house publishing tasks. Facilitate the creation or procurement of submission deliverables, including cover letters and regulatory forms. Perform detailed quality reviews of published submissions, including verification of content, bookmarks, hyperlinks, and tables of contents. Ensure compliance with regulatory standards and health authority guidance. Contribute to the development and implementation of internal business processes, standards, and publishing documentation. Suggest and support process improvements, including updates to software and business processes. Demonstrate the ability to influence without direct authority and maintain strong internal and external working relationships. Position Scope Works under supervision with regular oversight from the manager. Responsible for managing assigned projects independently within defined parameters. Provides regular project status updates to the manager. May assist with onboarding and training of new staff. Benefits The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long‑term disability insurance, short‑term disability insurance, paid parking/public transportation, paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually (These all are subject to applicable eligibility). Seniority level Entry level Employment type Contract Job function Legal #J-18808-Ljbffr

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