Associate Regulatory Affairs Specialist, Regulatory Operations and Publishing

Parker Staffing, LLC.; Belle Brook Estates (TN); Presencial; USD 55.000 - 75.000; Jornada completa

Descripción de la vacante

Parker Staffing, LLC. seeks an Associate Regulatory Affairs Specialist for a Bristol, TN site. You will support regulatory submissions, compliance, and product lifecycle management in a pharmaceutical setting.

The role requires a science degree and relevant regulatory experience. This is an onsite, direct-hire position with potential FDA reporting responsibilities and cross-functional coordination.

Formación

• Bachelor’s degree in a scientific discipline (chemistry, biology, microbiology, pharmacy, nursing, or related).
• 1+ year regulatory affairs certification or 2+ years pharma/FDA-regulated experience.
• Knowledge of FDA/EMA regulations, ICH guidelines, and cGMP.

Responsabilidades

• Prepare, review, and submit regulatory documents to the FDA (INDs, NDAs, ANDAs, amendments, etc.).
• Publish and validate electronic submissions using eCTD software.
• Coordinate with cross-functional teams to ensure timely submissions and regulatory compliance.
• Support CTD Modules 2 and 3 and other dossier content.
• Maintain controlled documents and submission records in DMS.

Conocimientos

Regulatory knowledge

Technical writing

Project management

Communication skills

Educación

Bachelor’s degree in a scientific discipline

Herramientas

eCTD publishing software

Adobe Acrobat

Microsoft Office

SAP

Descripción del empleo

Job ID:25788
Salary:$55,000 – $75,000 Per Year
Location: Onsite in Bristol, TN
Employment Type:Direct Hire
Schedule: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 ofRegulatory 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.

Smoking/vaping and the use of tobacco products are prohibited on all Company premises, including indoor and outdoor areas, parking lots, and Company-owned vehicles.

As part of our employment process, candidates who received a conditional offer may be required to undergo pre-employment drug testing.

Parker Staffing is an Equal Opportunity Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status.