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.
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 structured regulatory assignments with guidance 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], 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).
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.
Education: Bachelor's in related discipline
Experience: 1-3 years of regulatory /pharmaceutical experience
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.
Demonstrated ability to manage multiple tasks/projects/priorities simultaneously is required.
Excellent interpersonal, communication and listening skills
PHYSICAL & TRAVEL REQUIREMENTS:
5% (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 ...@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. Associated topics: dietary, dietetic, drug discovery, histologist, kinesiology, medical, microbiology, nephrology, physiology, transfection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.