Global Reg Sub Publishing Specialist (BB-32C78)
Found in: Talent IN
Description:Job Description -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. Minimum requirements Accountability Working experience within the pharmaceutical industry Technical knowledge of Pharmaceutical/Chemical Analytics/Quality Control and equipment qualification Regulatory Submissions Regulatory Submissions 5 years of relevant experience in Data Science BS in life sciences or a relevant discipline with min 5 years of professional work experience Fluent in English (Strong oral and written skills required). Additional language is an asset. 5-8 years submission publishing experience in Pharma or related industry Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria. Effective interpersonal skills, strong written and oral communication and presentation skills. Project management and time management skills to manage multiple ongoing projects simultaneously. Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives. Working knowledge of regulatory affairs. Works independently and with minimal supervision. Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
calendar_today4 days ago