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
PRIMARY DUTIES AND RESPONSIBILITIES: Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers for submission to Health Authorities [DMFs, MAFs, 510(k)’s] in compliance with regulations, guidelines and procedures
Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
Participate on project development teams and communicate regulatory progress, decisions, strategies, etc.
Review technical project documentation, certifications, correspondences, and external communications, as needed, providing guidance and direction where applicable.
Develop specific objectives and manage work assignments, with minimal 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, 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.
Education: Bachelor or Master’s degree in related discipline
Experience: Bachelors with 4-6 years; or Master’s degree with 1-3 years regulatory/pharmaceutical
Experience in regulatory CMC, preferably Biologics, 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.
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 custom...ers from locations in North and South America, Europe, Asia and Australia. West's 2016 sales of $1.5 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.