Under limited supervision, performs the preparation, review and submission of pre- and post-approval submissions to the Food and Drug Administration, using governmental guidelines and regulations. Essential functions include:
*Carries out responsibilities in accordance with the organization?s policies, procedures, and state, federal and local laws.
*Prepares timely original ANDAs, amendments, supplements, annual reports, and other regulatory documents for review and approval by Manager.
*Interfaces with other departments to provide Regulatory advice and obtain the necessary documents and drafts reports and narrative components in accordance with regulatory agencies? guidelines.
*Prepares, assembles, compiles and publishes regulatory submissions in electronic (eCTD) as required.
*Reviews and approves change controls, assigning the appropriate regulatory determination for eventual submission as required.
*Communicate with Regulatory Agencies as directed.
*Reviews, analyzes and generates technical documents from other departments or companies, e.g., summary of manufacturing processes, clarifications and explanations of Company procedures.
*Evaluates and researches any submission deficiencies, additional information or testing as requested by regulatory authorities.
*Participates in problem solving activities for assigned projects.
*Reviews and updates departmental SOP?s.
*Performs special projects assigned by Regulatory Affairs management.
*Complies with good housekeeping and safety practices.
*Trains and coaches lower level Regulator Affairs Associates.
*Ensures project deadlines and performance standards are established and met.
*Ensures compliance with all Company policies and procedures, including safety rules and regulations.
*Performs related duties as assigned.
Five (5) years' work experience in the pharmaceutical industry or three (3) years of satisfactory performance as a Regulatory Affairs Associate II. Knowledge of:
- Current Food and Drug Administration (FDA) regulations and guidelines.
- Current FDA/Regulatory Affairs submission requirements including eCTD format.
- Logistics and work of the pharmaceutical industry.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Current Company policies, practices and procedures, including safety rules and regulations.
Bachelor's Degree in Chemistry or related field from an accredited college or university.