Regulatory Affairs Specialist

Parker Staffing Services, LLC; Belle Brook Estates (TN); Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

Parker Staffing seeks a Regulatory Affairs Specialist for a Bristol, TN pharmaceutical client. You will support regulatory submissions and ensure compliance with FDA, ICH, and eCTD standards while coordinating with cross-functional teams.

Qualified candidates have a science degree and 2+ years of regulatory experience (or 4+ years in pharma). The role is on-site, direct-hire with a Monday–Friday schedule and a salary range of $55k–$75k.

Qualifikationen

• Bachelor’s degree in a scientific or healthcare-related field.
• 2+ years of regulatory affairs experience with certification, or 4+ years in pharma.
• Knowledge of FDA, ICH, cGMP and submission requirements.
• Experience with post-approval submissions, labeling, and promotional material review.
• Familiarity with eCTD publishing and electronic submissions.
• Strong organizational and project management skills.
• Ability to manage multiple priorities with minimal supervision.
• Strong written and verbal communication skills.
• Experience with SAP or regulatory publishing software is a plus.

Aufgaben

• Prepare and review regulatory submissions, including applications, amendments, supplements, annual reports, and labeling.
• Ensure submissions meet FDA, ICH, and eCTD requirements.
• Assess regulatory impacts of manufacturing, material, packaging, and process changes.
• Support post-approval product lifecycle and labeling activities.
• Coordinate with internal teams, external partners, and regulatory agencies.
• Assist with FDA correspondence and responses to regulatory requests.
• Support pharmacovigilance and required safety reporting.
• Review promotional and labeling materials for compliance.
• Monitor regulatory updates and maintain submission records.
• Manage multiple regulatory projects and deadlines.
• Other duties as assigned

Kenntnisse

Regulatory expertise

Documentation

Project management

Strong communication

Attention to detail

Ausbildung

Bachelor’s degree in a scientific or healthcare-related field

Tools

Microsoft Office

Adobe Acrobat

Database systems

SAP

eCTD publishing software

Jobbeschreibung

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 Regulatory Affairs Specialist, 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 and review regulatory submissions, including applications, amendments, supplements, annual reports, and labeling.

• Ensure submissions meet FDA, ICH, and eCTD requirements.

• Assess regulatory impacts of manufacturing, material, packaging, and process changes.

• Support post-approval product lifecycle and labeling activities.

• Coordinate with internal teams, external partners, and regulatory agencies.

• Assist with FDA correspondence and responses to regulatory requests.

• Support pharmacovigilance and required safety reporting.

• Review promotional and labeling materials for compliance.

• Monitor regulatory updates and maintain submission records.

• Manage multiple regulatory projects and deadlines.

• Other duties as assigned

Qualifications

• Bachelor’s degree in a scientific or healthcare-related field.

• 2+ years of regulatory affairs experience with certification, or 4+ years of relevant pharmaceutical industry experience.

• Knowledge of FDA, ICH, cGMP, and regulatory submission requirements.

• Experience with post-approval submissions, labeling, and promotional material review.

• Familiarity with eCTD publishing and electronic regulatory submissions preferred.

• Strong organizational and project management skills.

• Ability to manage multiple priorities and deadlines with minimal supervision.

• Strong written, verbal, and interpersonal communication skills.

• Proficiency with Microsoft Office, Adobe Acrobat, and database systems.

• Experience with SAP, regulatory publishing software, or metrics reporting is a plus.

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.