Manages FDA regulatory activities at Cody Laboratories in support of the submission and maintenance of Drug Master Files. Works in close cooperation with Lannett Company’s Regulatory Affairs Departments to provide support for drug product submissions involving materials manufactured at Cody Laboratories. Properly interprets and applies regulatory requirements relating to drug products and active pharmaceutical ingredients and provides regulatory guidance to key stake holders. Work is performed without appreciable direction and exercises discretion in determining technical objectives of assignments.
Essential Duties and Responsibilities (other duties may be assigned):
• Manages activities for the assembly of documentation required for drug master file submissions.
• Responsible for preparation and submission of new Drug Master Files (DMF) and maintenance/annual updates to existing DMFs.
• Interacts closely with corporate Regulatory Affairs for preparation of appropriate portions of drug product submissions for materials manufactured at Cody Laboratories.
• Actively engages in continuous improvement of cGMP regulatory compliance, standards, policies and procedures.
• Interfaces with regulatory agencies through written correspondence, face to face meetings etc. Interacts/negotiates with FDA regarding issues on submissions.
• Provides regulatory input and guidance for new product development teams. Participates in the creation of regulatory strategy for new products.
• Maintains an appropriate balance of technical information and resource considerations in preparation of regulatory filings.
• Reviews change control documentation to assess impact upon regulatory filings for affected materials. Coordinates the review of appropriate Cody Laboratories change controls by corporate regulatory affairs.
• Reviews deviations and investigations to assess impact upon regulatory filings.
• Represents regulatory affairs as a member of Cody Labs Material Review Board. Provides input to discussions concerning quality issues.
• Prepares and submits FDA Establishment Registrations to the FDA.
• Keeps abreast of changes in regulatory requirements for drug master files and drug products.
• Reviews and communicates emerging regulatory requirements to ensure compliance at Cody Laboratories.
• Leadership - Possesses strong leadership, mentoring, coaching and communication skills. Works well in a team environment, and is able to react quickly to changing business needs.
• Dependability - Highly self-motivated, well organized, ability to prioritize, manage and schedule to meet project and department objectives while maintaining quality goals. Responds to management direction and solicits feedback to improve performance.
• Effective administration skills, including ability to oversee all aspects of Regulatory Affairs responsibilities, and to delegate, as necessary to meet department goals.
• Must have excellent interpersonal skills, be highly self-motivated, well organized, and be able to develop alternative solutions to complex issues.
• Regulatory Management – looks for ways to improve and promote regulatory compliance and demonstrates accuracy and thoroughness.
• Planning/organizing – prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
• Adaptability – adapts to changes in the work environment, manages competing demands and is able to deal with frequent change, delays or unexpected events.
• Safety and security – actively promotes and personally observes safety and security procedures, and uses equipment and materials properly.
Bachelor’s degree (B.A. or B.S.) in Chemistry, Pharmacy, or Biological Science from four-year college or university and minimum of 8 years’ experience in Pharmaceutical Industry preferably in Quality Assurance, Quality Control Laboratory, or Regulatory Affairs at a pharmaceutical manufacturer.