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 ensuring the delivery of 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 support the execution of operational activities pertaining to the CMC submissions portfolio reporting critical issues to the line manager so they are addressed and milestones are being met. Adherence to established business processes and standard tool usage is expected.
On occasion the lead may contribute to broader improvement initiatives such as strategy development, process enhancement, solicit feedback, tool development, training roll , etc.
Responsibilities (% of time):
Regulatory Submissions Management
- Working knowledge 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 and contributes to 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 under the direction of the line manager
- Enables high quality CMC documents through content review and compliance submission ready standards
- 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
- Actively contributes to process and system improvements by demonstrating innovation and creative thinking
- Involved in department initiatives to create efficient, transparent and compliant practices
- Bachelor’s degree or advanced degree in Chemistry, Pharmacy, or closely related field is highly desirable.
- Minimum 3-5 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 is desirable
Location/Region: Lexington, MA