Remote Regulatory Affairs Lead — Pharma & Med Device

Jobgether; United States; Remote; USD 80,000 - 117,000; Full time

Job summary

Jobgether is seeking a Supervisor, Regulatory Affairs for a nationwide remote position based in the United States. You will lead regulatory operations across pharmaceutical and medical device portfolios, ensuring FDA compliance and timely submissions, while mentoring a team of labeling and listing professionals.

You will collaborate with QA, packaging operations, legal, and external partners to resolve complex compliance challenges, refine SOPs, and strengthen data integrity in regulatory

Qualifications

• Four to eight years of experience in Pharmaceutical or Medical Device Quality Assurance or Regulatory Affairs.
• Bachelor's degree in a relevant scientific or technical discipline preferred; equivalent practical experience considered.
• Strong understanding of FDA regulations, labeling standards, product listing obligations, and quality system procedures.
• Experience reviewing pharmaceutical labeling, packaging components, claims, and deviations; risk assessments and market action support is a plus.
• Familiarity with regulatory platforms such as Kallik, FACTS, or Veeva Vault QMS; knowledge of FDA drug listing submissions desirable.
• Excellent communication and stakeholder management skills; ability to lead cross-functional teams and drive SOP improvements.

Responsibilities

• Direct daily activities for labeling and listing specialists and provide coaching and performance support.
• Oversee labeling approvals and QA reviews for pharmaceutical products, ensuring compliance with regulatory standards.
• Review product claims, labels, and inserts; ensure accuracy and compliance for market materials.
• Lead investigations of packaging and labeling deviations; coordinate root-cause analysis and corrective actions.
• Coordinate Health Hazard Evaluations and support risk assessments to guide market actions.
• Oversee drug listing activities and UDI data submissions; maintain timely regulatory documentation.
• Develop and refine SOPs to strengthen compliance and improve workflow efficiency.
• Serve as regulatory liaison across QA, packaging, product development, and external partners.

Skills

Leadership

Regulatory knowledge

Labeling QA

Regulatory systems

Drug listing

Analytical thinking

Communication

Process improvement

Education

Bachelors degree

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Jobgether is seeking a Supervisor, Regulatory Affairs for a nationwide remote position based in the United States. You will lead regulatory operations across pharmaceutical and medical device portfolios, ensuring FDA compliance and timely submissions, while mentoring a team of labeling and listing professionals.

You will collaborate with QA, packaging operations, legal, and external partners to resolve complex compliance challenges, refine SOPs, and strengthen data integrity in regulatory