Regulatory Affairs Supervisor

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee regulatory programs, policies, and procedures to mitigate risks and enhance supply chain integrity.

• Collaborate across departments to devise solutions for intricate regulatory challenges.

• Develop and update standard operating procedures while ensuring compliance with established policies.

• Organize and manage the daily activities of senior specialists in labeling and listing.

• Implement and uphold internal policies and procedures that align with quality and regulatory goals.

• Supervise and assist in Quality Assurance approvals of labeling elements for pharmaceutical private-label brands.

• Evaluate and authorize labeling segments of Master Batch Records and Requests for Repackaging.

• Assess and validate claims, bio-food assertions, and California Proposition 65 evaluations.

• Manage the proofing and handling of Package Insert updates.

• Address complex packaging and labeling discrepancies with Quality Assurance managers.

• Lead efforts related to defect photographs, complaint samples, and root-cause analyses to establish market-action thresholds.

• Coordinate and draft Health Hazard Evaluations in collaboration with clinical medical safety professionals.

• Supervise drug listing activities and FDA submissions, including CARES Act reporting and FDA Certification timelines.

• Manage GUDID medical-device UDI submissions and Kallik regulatory labeling processes.

• Revise SOPs to enhance regulatory adherence, operational efficiency, and quality standards.

• Direct, oversee, and mentor Specialists and Senior Specialists.

• Serve as a liaison among Quality, Packaging Operations, Commercial Product & Development, Pharmaceutical Product Sourcing, and external vendor QA teams.

• Facilitate discussions on Quality Agreements.

⛳️ Requirements

• 4–8 years of experience in pharmaceutical or medical device Quality Assurance or Regulatory Affairs, preferably with Private Label exposure.

• Bachelor’s degree in a relevant scientific or technical discipline, or equivalent practical experience preferred.

• Knowledge of FDA Compliance Policy Guides (CPGs), 21 CFR Part 11, and USP standard testing.

• Familiarity with Kallik, FACTS, or Veeva Vault QMS database systems.

• Proficient understanding of eDRLS and I4I/A4L software applications for FDA drug listing submissions.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance.

• Paid time off program.

• Health savings account (HSA).

• 401k retirement savings plan.

• Early access to wages through myFlexPay.

• Flexible spending accounts (FSAs).

• Coverage for short- and long-term disability.

• Work-Life resources.

• Paid parental leave.

• Programs promoting a healthy lifestyle.