Regulatory Affairs Associate II
Role Purpose:
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 customers.
~ To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional secretarial service and assistance, and to contribute to the achievement of functional objectives.
~ Learns to use basic principals, theories, and professional concepts.
~ Applies company policies and procedures to resolve routine issues.
~ Contacts are primarily with immediate supervisor and other personnel in department or group
~ Works on problems of routine scope. Follows established policies and procedures.
~ Normally receives detailed instructions on all work Key Performance Indicators
~ Adherence to the companies policy and guidelines
~ Project & stakeholder feedback Education & Qualifications
Experience: Operations Management and Execution~ Collaborating across boundaries~ Cross Cultural Experience Pay ranges between $48-55/hr based on experience
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