Regulatory Affairs Associate
Stark Pharma, Trenton, NJ, United States
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Regulatory Affairs Associate
role at
Stark Pharma
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.
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
Required Qualifications
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
Preferred Skills
Prior experience supporting U.S. FDA submissions
Familiarity with regulatory document lifecycle management
Ability to manage multiple submissions and deadlines simultaneously
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Regulatory Affairs Associate
role at
Stark Pharma
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.
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
Required Qualifications
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
Preferred Skills
Prior experience supporting U.S. FDA submissions
Familiarity with regulatory document lifecycle management
Ability to manage multiple submissions and deadlines simultaneously
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