Shire Global Regulatory Project Management Associate in Cambridge, Massachusetts
For assigned projects, is responsible for working collaboratively with the Global Regulatory Lead (GRL) and cross functional project teams to provide project management support to ensure global regulatory strategies are developed and seamlessly executed upon, enabling successful filings with Health Authorities.
Supports the planning and execution of high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions. This includes major global regulatory submissions (NDAs, BLAs, MAAs, INDs, and supplementals) and other US submissions including amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc.,consistent with US regulatory requirements. Responsible for drafting and preparation of forms and cover letters required for US Submissions.
Maintains up-to-date knowledge of FDA regulations/guidance documents, and ICH guidelines.
Dependent on assigned program,work independently or assist the Global Regulatory Affairs Project Management and US (GPRMUS) Lead in providing project management support for product-specific global regulatory team meetings (GRTs) and cross-functional major submission team meetings to oversee, plan and deliver GRT goals and regulatory submissions.
For assigned programs, prepare meeting agendas, meeting minutes,and together with the team prepare effective issue and risk management plans.Develop and actively manage project timelines and integrated submission project plans. Prepare and distribute reports and trackers to communicate updates and project status.
For specified programs, proactively drive project teams, establishing an appropriate level of urgency and keen focus on deliverables. Track Project variances and assist in the identification of root causes. Conduct lessons learned sessions to identify areas for improvement.
Assist with the planning, coordinating and delivery of US submissions, including authoring of certain M1 components (e.g. drafting of forms and cover letters).
For speficied programs, coordinate and consult with GRL and other departments on the content, preparation and assembly of regulatory documentation in support of US filings. Perform final editorial checks of regulatory content prior to hand off to submission management.
Coordinate and provide operational support for FDA meeting requests, meeting rehearsals, briefing book preparations and assist in the preparation of meeting minutes of FDA meetings.
For specified programs, assist and support the GRPMUS Leads with project management and tactical exection of regulatory strategy deliverables for complex programs/projects.
Responsible for ensuring regulatory compliance for all assigned responsibilities.
Act as a conduit of information between assigned cross-functional submission teams and the GRT.
Work with submission management on the development of regulatory submissions.
Support and assist in the development, implementation and continuous improvement of PM tools and processes for global regulatory project management of new product licensures and lifecycle project management for existing products.
Education and Experience Requirements
BA/B.S in a scientific, healthcare or related field or equivalent experience
2+ years experience in Regulatory Affairs, Drug Development or similar. Project management experience preferred
Knowledge of FDA regulations and guidelines on drug development and the approval process for NDA/BLA and postmarketing supplements
Other Job Requirements
- 5-10% travel required mostly within North America.
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.
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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.