The Regulatory Product License Support Senior Specialist is responsible for the planning, publishing (paper, NeES, eCTD), review and dispatch of regulatory compliance submissions to global Health Authorities within required timeframes as well as maintenance of the global registration tracking tool. The primary accountability for this role is for the publishing of submissions. They also represent Global Regulatory Operations in special initiatives, process design and validation testing of new and upgraded software.
Plan and publish regulatory compliance submissions, ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes; Collaborate with GRO submission teams to ensure the submission portfolio is properly supported and work in a matrix environment to meet Shire's business needs; Stay current with new electronic submission and regulatory documentation practices issued from global health authorities; Propose new regional and global processes for paper and electronic submission publishing, including the evaluation of current processes; Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites. Maintain metadata in registration tracking tool for Shire global marketing authorizations; prepare reports utilizing metadata as required for business needs; maintain Pharmacovigilance System Master file Annex H.1, H.2 and H.5.
Contribute to new and updated processes and standards; Participate in validation testing of new and upgraded software; Responsible for the accuracy of information for submission metrics and registration information for senior management; Participate in GRA special initiatives.
Education & Experience Requirements:
• Bachelor's degree is required. Scientific and/or computer science field preferred.
• 3-5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.).
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.