Regulatory Affairs Specialist jobs in Columbia, SC

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:

· Receives, reports, and tracks adverse events and reactions for drug and device products

· Responds to requests for information on medically-related  product information for drug and device products

· Assists with additional work duties or responsibilities as evident or required.

· Performs other duties as assigned or apparent.

Primary Accountabilities:

NOTE: The primary accountabilities 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.

· Communicates directly with reporter regarding any adverse events reports.

· Evaluates adverse event reports and assesses regulatory status with regard to reporting requirements, in conjunction with the designated medical consultant.

· Processes adverse event reports (ADE) and medical device adverse event reports (MDR) from clinical trials and from marketed products in accordance with company procedures and regulatory requirements.

· Performs risk assessment and trending on adverse event reports

· Plans and authors complex regulatory documents for submission to regulatory health authorities.

· Participates in the preparation of aggregate safety reports, such as biannual safety reports to Ethics Committees and annual reports to regulatory authorities.

· Researches and processes literature review reports per regulatory guidance

· Provides support to the Regulatory Affairs Department by assisting with submitting establishment renewal/registration/updates required through Center for Drug Evaluation and Research - CDER Direct.

· Is able to manage and monitor government regulations, regulatory changes, and interpret and communicate requirements.

· Develops professional relationships with health authorities through supervised process, when required.

· Ensures that all documentation relating to adverse events, adverse event reporting and communications with regulatory authorities are properly archived in accordance with departmental and company policies and procedures.

· Assists in aspects of training for personnel and may supervise as appropriate.

· Supports management with implementation of departmental strategies and policies.

· Provides additional support to the Regulatory Affairs Department by assisting with organizational and research projects as needed.

Knowledge, Skills & Abilities:

· Relevant scientific degree (PharmD or RN preferred) with at least 2 years additional clinical or pharmaceutical experience.  Experience in Drug Safety and Regulatory Affairs strongly preferred.

· Ability to read, analyzes, and interprets complex scientific and medical reports and journals, as well as government regulations and guidance documents.

· Excellent written and verbal communication skills, along with the ability to effectively present information to regulatory authorities.

· Ability to write submissions and regulatory correspondence that conforms to a prescribed style and format.

· Critical thinking skills and ability to follow-through.

· Excellent organizational skills and attention to detail.

· Ability and willingness to change direction and focus to meet shifting organizational and business demands which includes the ability to multi-task and meet strict deadlines

· Experience with Adobe Acrobat, Excel, Power Point, and Word, and ability to learn new computer programs.

· Experience in working with confidential, ·controlled documents

· Position requires bending (desk to floor), lifting (up to 15 lbs), vision (20/20), standing (5%), sitting (90%), typing (80%) and walking (5%)

Salary range: Based on experience

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.

Nephron Pharmaceuticals is a drug free workplace.