SRG is seeking a Regulatory Affairs Manager for a year long contract that can be done remotely.
Summary: Under general direction, responsible for successfully filing original New Drug Application submissions and 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:
• 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.
• 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.
• Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
• 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.
Required Knowledge and Skills:
• FDA, ICH, SOP and cGMP standards, guidelines and regulatory compliance regulations.
•Annual reporting process and requirements for routine submissions
• Supervision and training practices and methods.
• Business, scientific and personal computer software applications.
• Business English usage such as, spelling, grammar and punctuation.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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