Shire CMC Submissions Lead in Lexington, Massachusetts
Under the direction of the line manager, the CMC Submissions Lead is responsible for execution of global CMC Regulatory Submissions operational activities in support of; pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, Post- Approval changes or compliance updates that pertain to a portfolio within a global franchise.
The lead will be tasked with establishing global submission activities and timelines in partnership with global and cross functional stakeholders in PD&TS, Biologics and Small molecule Operating Units, Regulatory Affairs and QA and will execute operational activities pertaining to the CMC submissions portfolio ensuring critical issues are addressed and milestones are being met. Adherence to established business processes and standard tool usage is expected.
On occasion the lead will be asked to contribute to broader improvement initiatives such as strategy development, process enhancement, solicit feedback, tool development, training roll out etc.
90% Regulatory Submissions Management
Proficient on global CMC regulatory submission requirements for small molecules, biologics, combination and /or plasma derived products.
Knowledgeable in global requirements for submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES).
Execute global planning and tracking for CMC submission activities for the franchise portfolio, ensuring appropriate stakeholder engagement and participation.
Monitors own performance and recommend process improvements, and facilitates implementation of changes, training and tools.
Supports operational excellence for CMC regulatory submissions.
Day-to-day management of CMC regulatory submissions
Provides guidance for submission eCTD granularity and global CMC submission requirements.
Enables high quality CMC documents through content review and compliance submission ready standards
Tracks new and updated global regulatory requirements and proactively provides summaries and recommendations as appropriate
Maintains awareness of current trends in regulatory requirements
Develops and maintains strong communication and collaboration with the stakeholders.
Be proficient on the Shire EDMS system and provides support to end users to ensure effective utilization of document management systems.
10% Process Improvements:
Actively contributes to process and system improvements by demonstrating innovation and creative thinking
Involved in department initiatives to create efficient, transparent and compliant practices
Education and Experience Requirements
Bachelor’s degree or advanced degree in Chemistry, Pharmacy, or closely related field is highly desirable.
Minimum 5-7 years’ experience in the Pharmaceutical Industry or relevant Regulatory environment including experience in CMC and regulatory submission management.
Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throughout out the development lifecycle is required.
Knowledge of Submission Ready standards application is required
Experience with documentum and publishing tools is desirable
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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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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.