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Regulatory Affairs Associate I
Contract: Florham Park, New Jersey, US
Salary Range: 34.00 - 38.00 | Per Hour
Job Code: 366504
End Date: 2026-01-21
Days Left: 28 days, 8 hours left
Position Details:
Industry: Pharmaceutical
Job Title: Regulatory Affairs Associate I – Submission Management
Duration: 12-Month Contract (Extension Based on Performance & Budget)
Location: Florham Park, NJ 07932 (100% Onsite)
Shift: Monday – Friday
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.s
- 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).
Job Requirement
- Regulatory Affairs
- Regulatory Submission Management
- eCTD Submissions
- Regulatory Publishing
- Submission Planning
- Content Planners
- Dossier Preparation
- Regulatory Compliance
- Quality Review of Regulatory Documents
- Risk Assessment and Mitigation
- FDA Submissions
- Global Regulatory Applications
- Document Control
- Regulatory Documentation
- Vendor Management
- Publishing Vendor Coordination
- In-house Publishing Support
- Submission Publishing
- Regulatory Forms Preparation
- Process Improvement
- SOP Development
- Regulatory Process Optimization
- Stakeholder Communication
- Pharmaceutical Industry Experience
- Documentum
- eCTDXPress
- ISI Publisher
- ISI Toolbox
- DocuBridge
- Insight Platform
- Adobe Acrobat
- Submission Tracking
- Regulatory Quality Assurance
Reach Out to a Recruiter
- Recruiter
- Phone
- Siddhi Kadakia
- siddhi.kadakia@collabera.com
Apply Now
Apply Now
