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.
With a focus on the Asia Pacific region, this role is responsible coordinating and authoring regulatory documentation and activities 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 moderately complex regulatory assignments with minimal guidance in support of West's products and processes with a focus on supporting China National Medical Products Administration (NMPA) and Asia Pacific registrations
Remain current on China NMPA and Asia Pacific regulations impacting West's products and services.
Identify guidance documents, regulations, international standards, etc. and with minimal guidance provide regulatory interpretation
Support CMC dossiers for submission to China NMPA and Asia Pacific registrations as needed
Participate on project teams as required and communicate regulatory impact, decisions, strategies, etc.
Review technical project documentation, certifications, correspondences, and external communications, as needed, providing guidance and direction where applicable.
Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires, LOAs (Letters of Authorization/Access) and technical packages.
Work to continuously improve regulatory databases, sharepoint sites and processes
Author, review and approve white papers, presentations and documentation to educate internal teams and customers on regulations impacting West products marketed in China and Asia Pacific regions as needed
Communicate/present on regulatory requirements and the impact of regulations to West's customers and internal commercial and technical teams
Provide support with change controls and customer regulatory requests, including regulatory letters and compliance questionnaires, as needed.
Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change.
Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
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.
Develop and analyze department systems to assure compliance and provides training when needed.
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 preferred
Experience: 2-4 years of regulatory/lab/pharmaceutical experience
Knowledge of CMC regulatory affairs, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
Experience interacting with regulatory agencies and industry groups
Demonstrated ability to meet deadlines, manage multiple tasks/projects/priorities and complex systems simultaneously
Attention to detail in composing and proofing materials
Must work well in a fast pace environment
Excellent interpersonal, communication and organizational skills
PHYSICAL & TRAVEL REQUIREMENTS:
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 email@example.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.
West Pharmaceutical Services