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 regulatory matters.

· Partner with and support clinical development, preclinical, quality, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle. 

· Function as a regulatory strategist with extensive ability to analyze complex situations and develop relevant and realistic plans for company programs with appropriate risk mitigation strategies. 

· Establish performance objectives and evaluate overall performance of regulatory affairs group. Evaluate team performance and monitor progress towards established goals.

Knowledge, Skills & Abilities:

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.

· Bachelor’s Degree in scientific discipline from an accredited college or university is required. An advanced degree is preferred. 

· 15 or more years’ experience working in a regulated environment with at least 10 years direct regulatory affairs and quality systems experience is required. 

· Experience with preparation and submission of regulatory filings (i.e. ANDAs, INDs, NDAs, amendments/supplements, annual reports, etc.) and thorough knowledge of FDA, EMA and ICH guidelines and regulations.  

· Capable of multi-tasking, setting priorities, and meeting timelines in a fast-paced, innovative environment with minimal supervision

· Knowledge and experience with cGMP, QA/QC fundamentals, SOP, Manufacturing, OSHA and DEP/EPA as they relate to the pharmaceutical industry is required. 

· Regulatory Affairs Certification (RAC) is highly preferred. 

· Training to include Leadership Training, GMP Compliance Auditing, etc. is preferred. 

· Excellent listening and verbal/written communication skills, to include public speaking, are required. 

· Agility in effective decision-making and negotiation is required. 

· Ability to coach and develop team members is also required. 

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.