Associate Regulatory Affairs Specialist, Regulatory Operations and Publishing

Associate Regulatory Affairs Specialist Of Regulatory Operations And Publishing

Bristol, Tennessee

Onsite

$55,000 – $75,000 Per Year

Non-Clinical Healthcare

Direct Hire

Monday – Friday, 8 AM – 5 PM

Due to the nature of the work environment and potential exposure to amoxicillin and related substances, candidates must not have a known allergy or sensitivity to amoxicillin.

Employment is contingent upon successfully passing a pre-employment background check and drug screening.

Our client is a well-established pharmaceutical manufacturer dedicated to producing essential medications that support the health and well-being of communities nationwide. With decades of industry experience, they operate a state-of-the-art production facility focused on quality, safety, and reliability. Their commitment to domestic manufacturing helps ensure a dependable supply of critical healthcare products while supporting high standards across all areas of production.

As the Associate Regulatory Affairs Specialist of Regulatory Operations and Publishing, you will support regulatory submissions, compliance activities, and product lifecycle management within a pharmaceutical environment. You will prepare and review regulatory documentation, coordinate with cross-functional teams, support FDA and safety reporting requirements, and help ensure products and processes remain compliant with applicable regulatory standards.

Essential Duties and Responsibilities

• Prepare, review, compile, and submit regulatory documents to the FDA, including INDs, NDAs, ANDAs, amendments, supplements, annual reports, and labeling updates.
• Publish and validate electronic submissions using eCTD publishing software.
• Build eCTD sequences, perform technical quality checks, and resolve publishing or validation errors.
• Support preparation of CTD Modules 2 and 3 and other regulatory dossier content.
• Maintain controlled regulatory documents and submission records within document management systems.
• Assess the regulatory impact of manufacturing, process, material, packaging, and documentation changes.
• Coordinate with cross-functional teams to ensure accurate, complete, and timely submissions.
• Support product lifecycle and post-approval regulatory activities, including CMC updates and safety reporting.
• Assist with FDA and other regulatory agency communications and submission requirements.
• Track submission status, deadlines, and regulatory documentation to support ongoing compliance.
• Other duties as assigned

Qualifications

• Bachelor's degree in a scientific discipline such as chemistry, biology, microbiology, pharmacy, nursing, or a related field.
• 1+ year of relevant experience with a Regulatory Affairs Certification, or 2+ years of pharmaceutical or FDA-regulated industry experience.
• Knowledge of FDA/EMA regulations, ICH guidelines, and cGMP requirements.
• Familiarity with regulatory submissions, CTD/eCTD formats, and electronic publishing processes.
• Experience with post-approval CMC submissions preferred.
• Strong technical writing, documentation, and communication skills.
• Ability to manage multiple projects, deadlines, and shifting priorities.
• Strong organizational, planning, and project management skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Proficiency with Microsoft Office, Adobe Acrobat, databases, and document management tools.
• Experience with FDA ESG, SPL/drug listing, regulatory publishing software, or SAP is a plus.
• Ability to occasionally travel and meet the physical requirements of a standard office environment.