What are the responsibilities and job description for the Regulatory Affairs Specialist II position at Fagron?
About The Job
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist II 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 II will assist and serve as a back-up to the Regulatory Affairs Specialist I & III for certain compliance critical tasks as required. The Regulatory Affairs Specialist II is responsible for supporting multiple areas of the operations organization to ensure regulatory compliance at all times.
In this role, you will be responsible for the following:
Basic Qualifications
Our Benefits
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist II 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 II will assist and serve as a back-up to the Regulatory Affairs Specialist I & III for certain compliance critical tasks as required. The Regulatory Affairs Specialist II is responsible for supporting multiple areas of the operations organization to ensure regulatory compliance at all times.
In this role, you will be responsible for the following:
- Schedules equipment calibration, reviews and maintains calibration and maintenance records.
- Reviews, Monitors and Maintains records for temperature and humidity.
- Maintains chemical control banding program.
- Creates, reviews, and maintains product labels and records.
- Performs bulk chemical regulatory inspection, documentation, and approval.
- Reviews drug substance pedigrees for accuracy and promptly resolves errors and omissions.
- Verifies FDA registration of all drug substance manufacturers.
- Reviews SDS documents for accuracy and resolves errors/omissions with suppliers.
- Maintains electronic SDS document system.
- Performs daily inventory counts and reconciliations of controlled substances.
- Performs controlled substance WO review and adjustments.
- Performs Schedule II customer order entry and file maintenance.
- Creates, submits, and maintains State and DEA (CSOS and ARCOS) reports.
- Assists and serves as back up to Regulatory Affairs Specialist I & III as required.
Basic Qualifications
- 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; or an equivalent combination of education and experience. Experience in the pharmaceutical industry a plus.
- Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals.
- The capacity to define problems, gather and analyze data, establish facts, and draw valid conclusions.
- Intermediate skills in Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
- Ability to lift 50lbs and work in warehouse environment with noise.
- Adapts effectively to changes in the work environment, manages competing demands, and handles unexpected challenges. Consistently reliable, meets commitments, and ensures responsibilities are covered when necessary.
- Maintains positive relationships, resolves conflicts constructively, contributes to a collaborative and supportive team environment, and communicates effectively.
- Provides prompt, high-quality service to internal and external customers. Approaches tasks with integrity, tact, and respect, ensuring alignment with organizational values and goals.
- Identifies and resolves challenges efficiently while fostering creativity and resourcefulness. Continuously seeks opportunities to improve processes and performance.
- Demonstrates sound decision-making, accuracy, and attention to detail while striving to maintain and enhance productivity and quality in all work efforts.
Our Benefits
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
- Competitive Salary
- Health, Vision, and Dental Insurance
- Company Paid Life Insurance
- Generous Paid Holidays
- Paid Volunteer Time
- Generous Paid Time Off and Rollover
- Company matching 401K and Retirement Savings Plans
- Employee Assistance Program
- Flexible working arrangements
