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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: (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
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Worksite address
florham park, NJ, 07932, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.