Regulatory Affairs Projects Manager

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Description

Regulatory Affairs Projects Manager

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

• Responsible for the hands on regulatory activities required to submit, approve and launch new products and for the maintenance of existing commercialized products.
• Executes regulatory activities according to project plans to assure new products meet submission, approval and commercial launch goals.
• Ensures project documents are complete and current, with all documentation performed as necessary.
• Supports manufacturing and procurement in the management of change to existing commercial products by managing, compiling and writing post-approval submissions
• Communicate regulatory and/or quality related issues, observations, problems affecting target submission dates to upper management
• Develops and approves labeling specifications in compliance with SOPs and FDA guidance
• Maintains regulatory files and data systems in compliance with SOPs and FDA guidance
• Attend conferences and training as required to maintain proficiency
• Acts as a representative of Regulatory Affairs in project team meetings
• Related activities include leading project team meetings, liaising with departments across the company to gather documents required for a submission package, and other hands-on regulatory activities required to maintain the life-cycle of commercial products.
  
  

Knowledge, Skills & Abilities

• Bachelor degree (BS or BA) in an applicable scientific or health science field such as biochemistry, chemistry, pharmacy or pharmacology
• Some hands-on experience in Regulatory Affairs, or a combination of an advanced degree in Regulatory Affairs or related field and relevant practical training in the field, is required.
• 2-5 years of experience in the pharmaceutical, medical device or other medical products/health care/self-care industry
• Excellent analytical skills and the ability to apply policies and general regulations to specific products or projects
• Excellent verbal and written communication skills
• Knowledge and understanding of scientific, regulatory and trade terminology
• The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures, and forms to effect method improvement and work simplification.
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to set clear targets and use performance measures to assess risk and opportunities, in order to effectively manage the assets of the business.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability, motivate and influence others, thinks globally and leverages diversity.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Use and continually develop leadership skills
• Salary range: Based on experience
• Hours of work: Monday thru Friday on an 8 hour shift, or as needed based on company demand.
  
  

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.