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Regulatory CMC Lead Biologics (Mgr level)
Under the guidance of the Director of Regulatory Affairs, manage Regulatory Affairs activities for execution of global CMC strategies for investigational and marketed products in US, Canada, EU and International regions. Lead the preparation and filing of CMC sections for regulatory submissions in a timely manner to meet corporate objectives. Manage interactions with Health Authorities for CMC issues.
Provide regulatory support, guidance and expertise to internal groups such as QA, Technical Operations, other GRA personnel, Pharmaceutical Sciences, and Clinical Operations to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.
Collaborate with US, Canada & International regulatory colleagues and provide support in the preparation of regulatory documentation.
30% Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.
20% Develop global CMC regulatory strategy for one or more investigational and marketed products
10% Collaborate with US & International regulatory colleagues in development of global CMC regulatory strategies.
10% Provide CMC regulatory guidance to project / product teams.
30% Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
EDUCATION & EXPERIENCE REQUIREMENTS
Bachelor s degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field.
Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in small molecule drug development and registration activities.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.