Director, Global Regulatory Affairs - CMC Strategy & Trials

Jobtailor; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking a senior Regulatory CMC leader to provide strategic, tactical, and operational oversight across therapeutic modalities and manufacturing technologies. The role requires deep knowledge of global CMC regulatory requirements for clinical trials and product registrations, plus the development and implementation of innovative regulatory strategies and platform approaches.

Ideal candidates will have 10+ years in Regulatory CMC or technical CMC, supporting development and/or

Qualifications

• BS degree required in science, engineering or STEM field; advanced degree preferred.
• 10+ years' Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic molecules.

Responsibilities

• Provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies.
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations.
• Development and implementation of innovative regulatory strategies and platform approaches.
• Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions.

Skills

Regulatory CMC Experience

Clinical Development

Product Registration

Regulatory Strategy Development

Technical CMC Knowledge

Education

BS in Science/Engineering

Job description

Jobtailor is seeking a senior Regulatory CMC leader to provide strategic, tactical, and operational oversight across therapeutic modalities and manufacturing technologies. The role requires deep knowledge of global CMC regulatory requirements for clinical trials and product registrations, plus the development and implementation of innovative regulatory strategies and platform approaches.

Ideal candidates will have 10+ years in Regulatory CMC or technical CMC, supporting development and/or