$140K — $150K
Regulatory Affairs Manager needs 5+ years’ experience
Regulatory Affairs Manager requires:
Ø FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations.
• 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.
• Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
• Company policies, practices and procedures, including safety rules and regulations.
• Principles and practices of budget preparation and administration.
Ø Creating, planning and implementing group goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
Regulatory Affairs Manager duties:
• 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 the assigned staff.
• Reviews and approves regulatory submissions (i.e. NDAs, amendments, 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 notices, specifications, batch records, standard test methods, etc.
• 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.
Valid through: 3/11/2021