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West Pharmaceutical Services, Inc. Specialist, RA in Exton, Pennsylvania

Reference #: 624220801Specialist, RAExtonPennsylvaniaWorking at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $1.84B in 2019. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.POSITION SUMMARY: This role is responsible for publishing regulatory submissions for West's products and processes, to ensure documents are formatted in accordance with appropriate regulatory guidelines and style guides and transmit via both paper and electronic media to health authorities in the US, EU, CA and Rest of World. Assist in support of established submission applications and maintenance of SharePoint structure and submission functionality within the Global Regulatory Affairs Unit. Maintain knowledge of current US and international regulations/guidelines/policies applicable to West's products and services.PRIMARY DUTIES AND RESPONSIBILITIES:Complete regulatory assignments with guidance in support of RandD and commercial programs with a with a focus on publishing and tracking of CMC dossiers for submission to Health Authorities [DMFs, Dossiers, MAFs, 510(k)'s] in compliance with current regulations, guidelines and procedures.Utilize eCTD, ESG and eSubmitter software applications; communicate issues directly to management when applicable and aid in bringing to resolution.Create and publish documentation in response to customer regulatory requests which includes regulatory letters, technical packages, abbreviated dossiers etc.Compliance check assigned technical project documentation, certifications, correspondences, and external communications, as needed.Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS Project, Adobe Pro, SharePoint and others as required.Assist with maintaining SharePoint structure for submissions 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.REQUIRED QUALIFICATIONS:Education: Bachelor's or Master's degree in related disciplineExperience: 2-4 years of regulatory /pharmaceutical experiencePREFERRED QUALIFICATIONS:Knowledge in submissions management and electronic publishing of CMC submissions to Global Health Related agenciesHands-on experience in the process of generating, reviewing and formatting documentation for worldwide regulatory submissionsExpert proficiency with Microsoft Word and Adobe AcrobatExperience in regulatory CMC with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).Demons