Under the guidance of the Associate Director of Regulatory Affairs, execute Regulatory Affairs activities for global CMC life cycle management strategies for investigational and marketed products in US, Canada, EU and International regions. Participate in the preparation and filing of CMC sections for regulatory submissions in a timely manner to meet corporate objectives.
Provide regulatory support and guidance 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 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 to support the life cycle management and global compliance of commercial biological products.
Contribute to regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
Participate in the preparation and filing of CMC sections of regulatory submissions
Help to execute the global CMC regulatory strategy for one or more investigational and marketed products
Collaborate with US & International regulatory colleagues in execution of global CMC regulatory strategies.
Education & Experience Requirements:
• Bachelor's degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field and a minimum of 3 years of related experience within a pharmaceutical company, CRO or similar organization or a Master's degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field and a minimum of 1-3 years of related experience within a pharmaceutical company, CRO or similar organization.
1 year International/Global CMC regulatory experience in drug development, registration and/or lifecycle management activities is also required.
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.
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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.