West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.

Position Summary:

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.

Responsibilities:

• 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.
  

Requirements:

• 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.
• Ability to read, write and speak English
• 10% - 15% travelling (Projects, Meetings, Training)
  

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a disability or special need that requires accommodation, please send an email to peggy.tayloe@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.