Regulatory Assistant - Full-time

We have a full-time opening for a Regulatory Assistant.

Must be able to work at least 1 shift per week and be available weekdays and weekends.

• Must have 2 or more years experience.
• Must have a high school diploma or equivalent.
• Be authorized to work in the United States.
• Must have reliable transportation.
• Background check required.

Wage: DOE

Qualifications: Bachelor's Degree in Science or a Health Related Field
Excellent oral and writing communication
Extensive Microsoft Office Experience
Extensive Adobe Acrobat/PDF Experience
Physical Requirements: Minor lifting (up to 50 lbs)
Supervisor: Pharmacist in Charge or designee
Appearance: Professional business casual
Attitude: Professional, serious and focused attitude for work at hand
Definition of Responsibility:
1. Coordinate submission of licenses to state boards and other regulatory authorities.
2. Complete license applications in collaboration with the Pharmacist-in-Charge
3. Facilitate all applications by
a. Tracking current license applications and renewals in a database.
b. Maintaining a hard copy filing system for all applications and renewals.
c. Ensuring the filing system is logical, organized and accessible.
d. Completing paper applications for review of PIC.
e. Seeking and applying for new 503B outsourcing permits.
f. Maintaining all mail associated with licensure.
g. Scanning all license to server and paper copy to file.
h. Ensuring licenses are mounted on the wall and removing expired ones.
i. Maintaining confidentiality of documentation.
j. Notarizing signatures potentially.
4. Updating the FDA listings of product lines.
a. Maintaining Structured Product Listings (SPL)
b. Strict organization and filing of electronic records related to drug products and labels
5. Assisting in Product Development duties while liaising with Quality Assurance
a. Assistance in Master Batch Record editing and creation. Requires use of Excel, PDF, and Word software.
b. Management of stability data and coordinating studies with direction of PIC & QA.
c. Assisting with notification or document requests to vendors if problems arise with items purchased.
6. Assisting in researching and data gathering for new products and projects, including, but not limited to
a. Researching peer reviewed literature (PubMed) for supporting stability and provide summary for supervisor approval.
b. Facilitating documentation requirements through direction of QA and PIC for new processes.
7. Other duties as assigned.
Knowledge, Skills, and Abilities Required to Job Function:
1. Knowledge of computerized information systems.
2. Ability to work without constant supervision.
3. Ability to foster a cooperative work environment.
4. Ability to organize and prioritize work assignments.
5. Knowledge of local, state, federal, and other regulations; knowledge of regulations and legal requirements governing the pharmacy, GMP, and compounding of sterile preparations.
6. Strong interpersonal and communication skills and the ability to work effectively across all departments and management levels.
7. Ability to maintain recordkeeping systems and procedures.
8. Demonstrates knowledge and compliance with the proprietary nature of operation.