System One Regulatory Project Manager in Madison, New Jersey
Job Title: Regulatory Project Manager
of Openings: 1
Contract Length: 12 mos
Under general direction, responsible for managing post approval changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps Company informed of significant regulatory issues that affect assigned products/projects.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
• Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Directs, coordinates and prioritizes the daily activities of assigned products
• Prepares, reviews and approves regulatory submissions (i.e. NDAs, amendments, annual report, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance’s.
• Interacts with various departments as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees.
• Review and approve change labeling and core safety document changes
• Implements policies to assure on-going compliance of Regulatory Affairs activities.
• Assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary.
• Interacts with the FDA to facilitate approval of the regulatory submissions.
• Maintains awareness of all regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.
• Meets project deadlines and established performance standards.
• Complies with all Company policies and procedures, including safety rules and regulations, and guides subordinates in this area.
• Performs related duties as assigned and any required updates to trackers or routine reports as applicable
Required Knowledge and Skills:
• FDA, ICH, SOP and cGMP standards, guidelines and regulatory compliance regulations.
•Annual reporting process and requirements for routine submissions and Pertinent Federal and State laws related to pharmaceutical regulatory affairs.
• Supervision and training practices and methods.
• Business, scientific and personal computer software applications.
• Business English usage such as, spelling, grammar and punctuation.
• Company policies, practices and procedures, including safety rules and regulations.
• Principles and practices of budget preparation and administration.
• Creating, planning and implementing group goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
• Responding to general and/or sensitive inquiries from management, employees and regulatory agencies.
• Communicating clearly and concisely, both orally and in writing.
• Managing multiple projects, duties and assignments.
• Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
• Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
• Establishing and maintaining cooperative working relationships with others.
• Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Physical Requirements and Working Conditions:
Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels. Work is performed in an office environment.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.