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: With a focus on the Asia Pacific region, this role is responsible for coordinating and publishing regulatory submissions for West s products and processes. Address customer regulatory requests and maintain knowledge of China NMPA and international regulations/guidelines/policies applicable to West s products and services.
PRIMARY DUTIES AND RESPONSIBILITIES:
Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on publishing and tracking of CMC dossiers for submission to China National Medical Products Administration (NMPA) and international Health Authorities [DMFs, MAFs, 510(k) s] in compliance with regulations, guidelines and procedures.
Create and publish documentation in English and Mandarin in response to customer regulatory requests which includes regulatory letters, technical packages, abbreviated dossiers etc.
Author/review assigned technical project documentation, certifications, correspondences, and external communications, as needed.
Assist with maintaining SharePoint structure and functionality within the Regulatory Affairs Unit.
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, and others as required.
Education: Bachelor's in related discipline (Science or Business preferred)
Experience: 0-3 years of regulatory /pharmaceutical experience
Bilingual; Fluent in English and Chinese/Mandarin (written and communication)
Knowledge in submissions management and electronic publishing of CMC submissions to health related agencies
Experience in regulatory CMC with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
PHYSICAL & TRAVEL REQUIREMENTS:
5 - 10% (meetings, trainings, projects)
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 ...@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.