Shire Regulatory Submission Specialist in Cambridge, Massachusetts
The PLS Submissions Manager is responsible for the daily maintenance of data within the global regulatory registration and commitment database, generating reports to fulfill health authority compliance requirements, and ad hoc requests from the business. They will also support the planning, publishing (paper, NeES, eCTD), review, and dispatch of regulatory compliance submissions to global Health Authorities within required timeframes. The primary accountability for this role is for the maintenance of the global registration and commitment database. They also represent Global Regulatory Operations in special initiatives, process design and validation testing of new and upgraded software.
% of Time
Job Function and Description
Maintain metadata in registration and commitment database for Shire’s global marketing authorizations; prepare reports utilizing metadata to support health authority requirements and compliance activities, and as required for business needs;
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;
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 and Experience Requirements
Bachelor's degree is required. Scientific and/or computer science field preferred.
0 - 4 years of pharmaceutical experience in a global regulatory environment preffered. Experience with document management system and database maintenance.
Key Skills, Abilities, and Competencies
Self-starter, who motivates, has tact, diplomacy, leadership skills and a flexible and positive approach.
Ability to identify and understand issues and propose creative and achievable solutions.
Strong attention to detail and accuracy.
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
Ability to cultivate internal and external relationships.
Applicable knowledge of the drug development process.
Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required. Microsoft SharePoint experience preferred.
Internal and External Contacts
Global Regulatory Operations
Global Regulatory Strategy
Country Regulatory LOCs
Global Regulatory Regulatory CMC
External (across R&D)
Global Drug Safety
Various other business units as required
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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, gender identity, 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.
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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.
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.