Shire Global Regulatory Project Management Lead (Associate Director) in Cambridge, Massachusetts

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Shire Human Genetic Therapies Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION : Global Regulatory Project Management Lead (Associate Director)

POSITION DESCRIPTION: Shire Human Genetic Therapies Inc. is seeking a Global Regulatory Project Management Lead (Associate Director) with the following duties: co-lead and facilitate 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 of varying compelxities; apply established project management practices in support of GRTs and cross-functional major submission teams including preparation of agendas, documentation of decisions, development and active management of timelines, effective issue and risk management; drive project teams, establish appropriate level of urgency, and maintain focus on deliverables; track Project variances and identify root causes; conduct lessons learned sessions to identify areas for improvement; plan and deliver US submissions, particlarly those for highly complex programs/products, which will include authoring of certain M1 components where applicable; 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; ensure regulatory compliance for all assigned responsibilites; 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; mentor and train staff within department and assist in providing leadership support to the GRPMUS team; support and contribute to 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; coordinate regulatory operations in international countries, and work in a fast paced environment with multiple competing tasks and demands; develop strategies and creative approaches for global new product registrations and modifications that directly impact the effectiveness of the products; implement regulatory systems to support global regions in planning and tracking regulatory status, submissions, forthcoming activities, requirements, and key timelines in order to ensure compliance and successful communication with health authorities; manage and prepare regulatory submissions and projects using precedent and previous experience to achieve regulatory and commercial goals, delivering solutions to the business.

REQUIREMENTS: Bachelor’s degree in Chemistry, Pharmacy, Life Science or related field or foreign academic equivalent plus 4 years related experience. Will accept any level of experience in the following required skills: coordinate regulatory operations in international countries, and work in a fast paced environment with multiple competing tasks and demands; develop strategies and creative approaches for global new product registrations and modifications that directly impact the effectiveness of the products; implement regulatory systems to support global regions in planning and tracking regulatory status, submissions, forthcoming activities, requirements, and key timelines in order to ensure compliance and successful communication with health authorities; manage and prepare regulatory submissions and projects using precedent and previous experience to achieve regulatory and commercial goals, delivering solutions to the business.

Full time. $135,000.00 - $150,000.00/year. Competitive compensation and benefits.

Qualified applicants can apply directly to the Shire careers page at: https://jobs.shire.com. Please reference job #R0026876. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

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Reasonable Accommodations

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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.