Senior Director of Regulatory Affairs

Description

Senior Director of Regulatory Affairs

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, with additional distribution centers in Kentucky and Arizona. 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:

The Sr. Director of Regulatory Affairs will be a collaborative leader with the ability to develop an effective regulatory strategy as well as a streamlined regulatory path through the product lifecycle from conception/discovery to post approval. This role is responsible for developing and maintaining positive working relationships with primary regulators, such as the US Food and Drug Administration (FDA), leading the regulatory affairs team, and leading the preparation and submission of all regulatory documents. 

· Assumes a key leadership role directing the Regulatory Affairs group of a Pharmaceutical / Medical Device Company.

· Develop and execute regulatory strategy for product lifecycle, new product submissions, and achieve timely filings of regulatory submissions.

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

· Performs other duties as assigned or apparent.

Primary Accountabilities:

· Responsible for providing leadership and oversight to the Regulatory Affairs team while defining and overseeing the execution and maintenance of the Regulatory Management System. 

· In Collaboration with executive team, lead the development of regulatory strategies and objectives that result in the successful registration, approval, and commercialization of company products. 

· Responsible for overseeing all aspects of pharmacovigilance operations and ensuring compliance with regulatory requirements.

· Plan and execute regulatory strategies and activities across the company portfolio to assure compliance based on regulations and guidance documents. 

· Maintains regulatory records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory guidelines.

· Proactively provide strategic and tactical regulatory guidance on complex development matters to multidisciplinary teams ensuring regulatory activities are in alignment with goals and objectives. 

· Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

· Provide leadership and professional development for Regulatory Affairs staff to meet and exceed expectations with regards to timely and quality submissions. Coach and mentor staff to build capabilities within the team. 

· Direct interaction with regulatory authorities for strategic/complex matters associated with projects/product submissions. 

· Maintain key contacts in the regulatory field to keep abreast of current regulatory events, to assess any potential impact, and to implement changes accordingly. 

· Provide regulatory oversight of program documents including target product profiles, development plans, as well as non-clinical and clinical protocols and reports. 

· Conduct risk assessments and develop mitigation strategies for regula