Regulatory Affairs Licensure Specialist - Military veterans preferred

Nephron Pharmaceuticals

Description:

Corporate Statement

Nephron Pharmaceuticals Corporation is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. Nephron is currently working on research and development projects that include over 50 new products. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

Prepare, file and maintain all new and renewal licenses for both Nephron Pharmaceuticals Corporation and Nephron 503b Outsourcing Facility.

Primary Accountabilities:

· Coordinates, prepares and submits state and federal licenses/permits in a complete and timely manner

· Maintains current status with all regulations and requirements related to any changes that occur in ownership, location, main contact at distribution site and/or manufacturer plant, to include changes that occur within Nephron 503b Outsourcing division as requested by management

· Performs research and review of conflicting regulations and follow the current most stringent law or regulation

· Communicates with Regulatory Affairs management on a regular basis with updates on status of all licensing matters

· Maintains current status with all regulations and requirements of all state and federal licensing as they pertain to pharmaceuticals and 503b Outsourcing Facilities

· Participates in internal audits

· All other duties apparent or requested by Management

· There are certain business/occupational licenses/permits/registrations, which are obtained or renewed by departments outside of Regulatory Affairs Department. The Regulatory Affairs Management or licensee designee will assist in obtaining, renewing, posting, and/or distributing these licenses as needed

NOTE: The primary accountabilities above and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.

Knowledge, Skills & Abilities:

-Bachelor or Associate Degree preferred

-Excellent communication skills, both verbal and written

-Highly organized

-Self Motivated

-Strong computer skills

EEO Statement:

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Requirements:

PI242864881