Senior CMC Regulatory Submission Manager

Position Details: 

Client Direct Client

Location Lexington, MA

Job Title Senior CMC Regulatory Submission Manager

Duration 1 Year+

Must have skill-set [Job Description] Job Summary

Under the direction of the line manager, the CMC Regulatory Submissions Manager supports the management and oversight of the CMC Regulatory Submissions for Global Portafolio of early development programs (IMPD/CTA/IND). The Regulatory Submissions Manager is also responsible for execution of the global CMC submission process (Creation, Review, Approval, Submission and Commercial Implementation of CMC Dossiers for Marketing Applications and Post- Approval) by working closely with Product Development, Regulatory, QA, GPT and MS&T crossfunctional project teams to support the execution of operational activity, monitor adherence to the process, periodically evaluate the metrics, revise the process as required, implement changes and provide appropriate training and tools. The manager will be responsible for tracking global submission activities for Biologics and Chemically Synthesized Products. In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions and Document Compliance department with expertise in general pharmaceutical development of global products, submission ready standards and eCTD requirements

Responsibilities: 

• Knowledge of global CMC regulatory submission requirements

• including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES).

• Department lead on the clinical and commercial CMC submission

• processes.

• Tracking global submission activities. Oversees regulatory

• submissions trackers

• Supports the monitoring of global CMC process, evaluation of metrics periodically, monitoring the process, supports changes and provides training and tools. Maintains operational excellence of the process.

• Oversees management of the content planning of regulatory

• submissions within PD.

• Provides guidance for submission eCTD granularity.

• Maintains oversight and executes documents to submission ready

• standard for CMC regulatory submissions.

• Maintains global module 3 templates.

• Oversees management of Quality 3D domain: Quality Folder, PD file guide, Annex 3, Submission ready standards guide.

• Maintains awareness of current trends in regulatory requirements

through literature searches and networking.

• Basic knowledge of US, Canadian, European regulatory requirements for APls and drug products for biologics and chemically synthesized.