Regulatory Affairs Associate

Description

Regulatory Affairs Associate

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:

We are seeking a detail-oriented professional for the position of Regulatory Affairs Associate, with a primary focus on drug safety, including pharmacovigilance, product recalls, and regulatory compliance. This role involves preparing and managing regulatory submissions, monitoring and interpreting regulatory guidelines, collaborating with quality assurance on product quality complaints, and contributing to regulatory strategy development. The ideal candidate will demonstrate strong analytical skills, excellent communication abilities, and a proactive approach to problem-solving, as well as a solid understanding of regulatory requirements and the ability to work collaboratively across teams to drive compliance and enhance patient safety outcomes. 

Primary Accountabilities: 

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

· Maintain and apply knowledge of laws, regulations, guidance, and procedures related to regulatory compliance, with a focus on US-FDA requirements and industry standards.

· Monitor regulatory changes and ensure that internal processes align with current requirements, disseminating updates to relevant teams.

· Analyze safety and regulatory data for drugs, devices, and compounded drugs to identify trends and risks aligned with regulatory standards.

· Process Adverse Drug Events (ADE), Adverse Events (AE) and customer complaints, ensuring timely follow-up, proper documentation, and trend tracking. 

· Prepare clear, concise, and timely regulatory reports, including Individual Case Safety Reports (ICSRs), Periodic Adverse Drug Event Reports (PADERs), and Medical Device Reports (MDRs), ensuring compliance with FDA reporting timelines and guidelines.

· Assist in developing and maintaining pharmacovigilance SOPs to ensure alignment with evolving regulatory requirements.

· Support product recalls by ensuring timely and effective action in compliance with regulatory requirements. 

· Review and support regulatory submissions (e.g., INDs, NDAs, ANDAs, 510(k)s) for completeness, accuracy, and compliance with regulatory guidelines (FDA, ICH, etc.).

· Verify that all technical content is scientifically accurate and meets formatting requirements (e.g., eCTD).

· Collaborate with cross-functional teams to support safety and regulatory compliance initiatives. 

· Participate in ongoing training to maintain expertise in regulatory affairs, internal processes, and industry practices.

· Provide support for ad-hoc projects, including special investigations, safety assessments, and regulatory submissions as needed.

· Identify emerging risks in compliance or safety and collaborate on corrective and preventive action plans to mitigate potential issues.

· Support inspections and audits as needed.

· Aggregate and present findings to management, ensuring transparent communication and alignment with organizational goals.

· Support the implementation of pharmacovigilance tools and strategies, ensuring alignment with regulatory requirements and organizational goals.

· Contribute to fostering a culture of open communication, continuous improvement, and shared accountability for compliance and safety outcomes.

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, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

Requirements

Qualifications: 

· A degree in a relevant scientific field is required; a Doctorate of Pharmacy (PharmD) highly preferred for this role. 

· The ideal candidate should have at least 1-3 years of relevant training or experience in the pharmaceutical industry, preferably within a GMP environment.

· Experience in pharmacovigilance, data management, or regulatory compliance is preferred but not required.

· Strong attention to detail with the ability to manage deadlines effectively.

· Excellent verbal and written communication skills, as well as strong interpersonal skills, are required.