This role is responsible for coordinating and authoring regulatory submissions for West’s products and processes. Address customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services.
Complete structured regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of China dossiers for submission to NMPA [Dossiers, LOAs], customer requests, etc. in compliance with regulations, guidelines and procedures.
Support project development teams and communicate regulatory progress, decisions, strategies, etc., with guidance.
Review assigned technical project documentation, certifications, correspondences, and external communications, as needed.
Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires, LOAs (Letters of Authorization/Access).
Support in strengthening the existing contacts and establishing new contacts with NMPA officials in Beijing, Shanghai and other provinces for pharmaceutical packaging.
Develop specific objectives and manage work assignments, with guidance, in an effort to achieve personal objectives in conformance with overall business goals.
Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change.
Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.
Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required.
Bachelor's or Master’s in related discipline.
1-3 years pharmaceutical industry experience
Knowledge of Project Management
Knowledge of CMC regulatory affairs and regulatory operations including sterile pharmaceutical products produced by aseptic processing, direct interactions with regulatory agencies and management of regulatory support systems is a plus.