Shire Regulatory Product License Support Senior Specialist in Cambridge, Massachusetts
The Product License Support (PLS) Sr. Specialist is responsible for the planning, publishing (paper, NeES, eCTD) with an emphasis of FDA Form 2253 Submissions, review and delivery of GRO-managed regulatory submissions to global Health Authorities within required timeframes. This role is also responsible for non-submission regulatory reporting on behalf of GRA. The PLS Sr. Specialist represents GRO in special initiatives, process design and validation testing of new and upgraded software
Primarily responsible for the planning and publishing of the GRO-managed submissions portfolio with an emphasis of FDA From 2253 Submissions, with accountability of monitoring the submission forecast and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
Maintain compliance for non-submission regulatory reporting on behalf of GRA, ensuring GRO is managing data according to agency requirements and internal processes
Maintain effective relationships with R&D contributing groups, ensuring timelines and requirements are mutually understood and in line with Shire and health authority standards.
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.
Interpret regulatory guidelines to produce regulatory submission business requirements and ensure that those requirements are implemented where appropriate at local level.
Operate as Subject Matter Expert in dossier types, processes and/or technical solutions, with responsibility for training and mentoring fellow colleagues.
Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites.
Review R&D documents to ensure compliance with Shire’s submission ready standards guidelines.
Contribute to new and updated process and standards.
Participate in validation testing and requirements gathering of new and upgraded software.
Responsible for the accuracy of information for submission-related metrics for senior management.
Participate in GRA special initiatives.
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.).
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.
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.