What are the responsibilities and job description for the Regulatory Submission Specialist position at Stark Pharma?
Job Title: Regulatory Submission Specialist
Location: Florham Park, NJ (Hybrid)
Experience: 5 Years
Duration: 12 months contract
Eligibility: US Citizens or Green Card holders only
Job Summary
The Regulatory Submission Specialist 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.
Key Responsibilities
Location: Florham Park, NJ (Hybrid)
Experience: 5 Years
Duration: 12 months contract
Eligibility: US Citizens or Green Card holders only
Job Summary
The Regulatory Submission Specialist 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.
Key Responsibilities
- 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 PromoMats 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 DocuBridge 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