Shire Associate Director, Global Regulatory Lead in Cambridge, Massachusetts

  • The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products. This role includes the lead regulatory responsibility for support of US and global registration and life cycle support, and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating support via a Global Regulatory Strategy Team composed of core regulatory support functions.

  • Serves as the US and global regulatory strategy lead for assigned projects. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Proactively identifies and assesses regulatory risks associated with product development for assigned projects.

  • Leads Global Regulatory Team and represents regulatory affairs function on key internal program teams.

Coordinates cross-functional group of regulatory professionals as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.

Leads the development of strategic plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.

Designs and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations.

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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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.