Regulatory Affairs Specialist
Fagron
Summary
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will be primarily responsible for supporting compliance with applicable FDA, DEA, State Board of Pharmacy and OSHA regulations as well as all applicable company policies. The Regulatory Affairs Specialist will assist and serve as a back up to the Regulatory Affairs Manager for compliance critical tasks as required. The Regulatory Affairs Specialist is responsible for supporting multiple areas of the operations organization to ensure regulatory compliance at all times.
Job description
About the Job
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will be primarily responsible for supporting compliance with applicable FDA, DEA, State Board of Pharmacy and OSHA regulations as well as all applicable company policies. The Regulatory Affairs Specialist will assist and serve as a back up to the Regulatory Affairs Manager for compliance critical tasks as required. The Regulatory Affairs Specialist is responsible for supporting multiple areas of the operations organization to ensure regulatory compliance at all times.
Basic Qualifications
- Performs bulk chemical label inspection, documentation and approval.
- Reviews drug substance pedigrees for accuracy and promptly addresses errors and omissions.
- Verifies FDA registration of all drug substance manufacturers.
- Maintains change control for drug substances.
- Manages new item set up in ERP system.
- Performs facility and equipment safety inspections.
- Maintains first aid kits and respirator supplies for respiratory protection program.
- Performs employee safety training and emergency drills.
- Sets up and maintains supply item product labels.
- Performs daily inventory counts of controlled substances.
- Assists and serves as back up to other Regulatory Affairs positions as needed.
Core Competencies
- Demonstrates dependability, punctuality, ethical behavior, and accountability while consistently upholding company policies, expectations, and core values.
- Speaks and listens clearly; maintains respectful and confidential interactions; engages constructively in teamwork and feedback; builds positive peer relationships.
- Adjusts effectively to change, competing demands, or unforeseen challenges; applies resourcefulness and innovation to resolve issues and improve processes.
- Responds efficiently to service needs; supports internal and external stakeholders; aligns efforts with organizational goals and ensures quality, timely work.
- Applies sound decision-making and analytical thinking; understands business implications; involves others appropriately in decisions and maintains strategic focus.
- Respects and embraces cultural differences; fosters inclusive interactions; reflects knowledge of EEO policies in daily practices and teamwork.
Requirements
- High School Diploma or GED equivalent required
- Associate Degree, Bachelor's Degree or industry equivalent experience preferred
- Minimum of two (2) years of progressive responsibilities in regulatory affairs experience preferred
- Experience in the pharmaceutical industry a plus
- Knowledge of FDA, DEA, State Board of Pharmacy and OSHA regulations
- Bulk chemical label inspection, documentation and approval
- Review drug substance pedigrees for accuracy
- Verify FDA registration of drug substance manufacturers
- Maintain change control for drug substances
- Manage new item set up in ERP system
- Perform facility and equipment safety inspections
- Maintain first aid kits and respirator supplies
- Perform employee safety training and emergency drills
- Set up and maintain supply item product labels
- Perform daily inventory counts of controlled substances
Benefits
- Competitive Salary
- Health Insurance
- Vision Insurance
- Dental Insurance
- Company-Paid Life Insurance
- Paid Holidays
- Paid Volunteer Time
- Paid Time Off
- 401(k) Matching
- Retirement Savings Plans
- Employee Assistance Program
- Flexible Working Arrangements
Company overview
Fagron is a global pharmaceutical company specializing in pharmaceutical compounding and sterile outsourcing services, dedicated to personalizing medicine to meet individual patient needs. Founded in 1990 in Rotterdam, Netherlands, the company operates in 35 countries worldwide, serving over 150,000 customers across more than 55 countries. Fagron's core business focuses on providing products and services for pharmaceutical drug compounding to hospitals, pharmacists, and healthcare institutions, enabling the creation of tailor-made medications that address specific patient requirements not met by mass-produced pharmaceuticals. The company's innovative approach extends the range of available medications and keeps affordable treatments accessible for patients who need specialized formulations. With Rafael Padilla as CEO, Fagron has grown into a publicly traded multinational group listed on Euronext Brussels and Euronext Amsterdam, employing over 2,000 professionals globally. The company's comprehensive portfolio includes pharmaceutical compounding materials, sterile outsourcing services, and specialized healthcare solutions that support pharmacists and prescribers in delivering personalized patient care.