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Manager Regulatory Affairs CMC
Under the direction of the Director/Associate Director of Regulatory Affairs, the Manager RA-CMC will direct and manage Regulatory Affairs activities for developing global regulatory CMC strategies across product life cycles & execution in North America. Provide collaborative support for execution of global strategies to other regions (EU & International). Manage submissions and interactions with the FDA and Health Canada for CMC issues. Provide support to other HA interactions as required.
Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams 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. Manage preparation of US and Canada applications in a timely manner to meet corporate objectives as well as act as be the focal point with the submission management group for international filings
Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives
30% Provide key submission strategies and participate in the preparation and filing/review/edits of CMC sections of regulatory submissions and interactions with regulatory agencies.
25% Develop global CMC regulatory strategy for one or more investigational and marketed products
20% Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
15% Collaborate with EU & International regulatory colleagues in development of global CMC regulatory strategies.
10% Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines
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 biologics and/or 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.