Regulatory Affairs Associate

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Job Title: Regulatory Affairs Associate

Location: Florham Park, NJ (Hybrid)

Experience: 5+ Years

Duration: 12+ months contract

Eligibility: US Citizens or Green Card holders only

The Regulatory Affairs Associate/Regulatory Publisher will support U.S. regulatory submissions and publishing activities within a pharmaceutical environment. This role focuses on eCTD publishing, promotional material submissions, and regulatory documentation management while ensuring compliance with FDA regulations and internal standards.

• Support preparation, publishing, and submission of U.S. regulatory filings in eCTD format
• Perform eCTD lifecycle management including publishing, validation, and quality checks
• Manage AdPromo and Promo Mats submissions in compliance with FDA requirements
• Compile, format, and publish regulatory documents using approved tools and templates
• Ensure accuracy, completeness, and timeliness of regulatory submissions
• Coordinate with Regulatory Affairs, Labeling, and cross-functional teams to meet submission timelines
• Maintain submission archives and regulatory documentation in electronic systems
• Troubleshoot publishing issues and resolve technical errors related to eCTD submissions
• Follow FDA guidelines, SOPs, and regulatory standards for submission readiness

• Bachelor's degree in Life Sciences, Pharmacy, or a related field
• 0 3 years of experience in Regulatory Affairs or Regulatory Publishing within the pharmaceutical industry
• Hands-on experience with eCTD publishing and submissions
• Experience with AdPromo and promotional material submissions
• Working knowledge of FDA regulations and submission processes
• Proficiency with regulatory publishing tools such as Docu Bridge and eCTDXpress
• Strong attention to detail and document management skills
• Ability to work in a hybrid onsite/remote environment
• Strong communication and coordination skills

• Prior experience supporting U.S. FDA submissions
• Familiarity with regulatory document lifecycle management
• Ability to manage multiple submissions and deadlines simultaneously