Associate RA Specialist Operations and Publishing
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Before you apply
LocationBristol-Tennessee
Typefull-time
SeniorityEntry
Experience1+ yrs
Company size1,001–5,000 people
PostedOct 7, 2026 · 1mo ago
Verified live3d ago
At a glanceSummarised by Seekless from the posting.
Bachelor's degree in a scientific area of interest (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing)
Minimum of one years’ experience plus a Regulatory Affairs Certification or two years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment
Competency with regulations, policies, and procedures relating to company and regulatory guidelines
Understanding of ICH guidelines, FDA/EMA regulations, and cGMP requirements related to drug substance and drug product manufacturing
Ability to multitask and manage multiple projects with interdisciplinary teams
Effective communication (verbal and written) with external and internal customers, vendors, and regulators
Exceptional technical writing and document-authoring capabilities
Solid interpersonal (verbal and written) communication skills at all levels
Knowledge in working with post-approval CMC submissions to FDA
Strong planning and organizational / project / workload management skills
Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
Strong ability to work independently as well as in a team environment
Ability to drive projects to completion with minimal guidance
Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema
Regulatory publication experience using eCTD software
Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry
Experience with FDA ESG, SPL submissions/drug listing
Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat, including database management and support
SAP experience
Skills
eCTD publishing software
Adobe Acrobat
SAP
FDA ESG
SPL submissions/drug listing
Overview
USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We’re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.
About the role
Responsible for supporting the preparation, publishing, validation and submission of regulatory documents to the FDA. Will be responsible for product and submission lifecycle management under the direction of department Director. Activities may include but are not limited to:
• Compilation/review of original applications (INDs, NDAs, ANDAs), amendments, supplements, annual reports and product labeling in accordance with FDA and ICH guidelines.
• Interface with cross-functional teams to author, review, and compile high-quality regulatory dossiers (such as CTD Modules 2 and 3) to secure and maintain product approvals from health authorities such as FDA.
• Manage controlled regulatory documents within document management systems.
ROLES & RESPONSIBILITIES:
•
Product support activities: Author, review and compile FDA Submissions (e.g., NDA/ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages and Periodic Adverse Drug Experience Reports (PADERs)) as agreed upon with change control review/approval and management and in accordance with FDA and ICH guidelines
•
Publish electronic submissions using eCTD publishing software ensuring accuracy and completeness of submissions. Build and validate eCTD sequences and perform technical validation check prior to submission. Resolve any publishing validation errors and submission deficiencies.
•
Assessment of regulatory impact of proposed changes to manufacturing facilities and processes, raw material sources, packaging components, and/or controlled documents.
•
Support interactions with FDA and other regulatory agencies.
•
Additional responsibilities as assigned by management.
KNOWLEDGE, SKILLS AND ABILITIES:
•
Competency with regulations, policies, and procedures relating to company and regulatory guidelines. Understanding of ICH guidelines, FDA/EMA regulations, and cGMP requirements related to drug substance and drug product manufacturing.
•
Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred. Regulatory publication experience using eCTD software is preferred.
•
Ability to multitask and manage multiple projects with interdisciplinary teams.
•
Effective communication (verbal and written) with external and internal customers, vendors, and regulators. Exceptional technical writing and document-authoring capabilities.
•
Solid interpersonal (verbal and written) communication skills at all levels.
•
Knowledge in working with post-approval CMC submissions to FDA.
•
Strong planning and organizational / project / workload management skills.
•
Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects.
•
Strong ability to work independently as well as in a team environment.
•
Ability to drive projects to completion with minimal guidance.
•
Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus.
•
Experience with FDA ESG, SPL submissions/drug listing is preferred.
•
Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat, including database management and support. SAP experience a plus.
QUALIFICATIONS:
•
Bachelor’s degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing).
•
Minimum of one years’ experience plus a Regulatory Affairs Certification or two years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment.
TRAVEL REQUIREMENTS & WORKING CONDITIONS:
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