What are the responsibilities and job description for the Regulatory Project Manager position at MakroTech?

Job Description

Workload

Develop & Maintain IND / NDA Submission Content Plans (SCP)
Develop & Maintain Project Timelines for IND submissions / Initial NDA
Proactively manage & track toward submission deliverables
Transfer files for Submission to Publisher
Provide updates wrt NDA Progress
Liaise with Regulatory Consultant & Publisher (Reg Ops) on submission deliverables and submission dates
Oversee progress by other all staff towards timelines & Project goals

Requirements

Activities

Participate in Weekly Company Team Meeting

Participate in Meetings with Regulatory Consultants / Experts as necessary

Participate in Meetings with CRO (P3 CSR) as necessary wrt Timeline

Establish 1 : 1 Meetings with CMC, Clinical, Nonclinical as necessary to manage project

Establish Meetings with NDA project staff (if applicable)

Establish Meetings with Publisher

Requirements

Project management skills

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