Global Regulatory CMC Consultant (12-Month Contract)

Greenhouse Software, Inc.; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

ClinChoice is seeking an experienced Regulatory Affairs CMC Consultant for a 12-month contract with extension potential. You will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global submissions.

Collaborate with Regulatory Affairs, R&D, Quality, and Supply Chain to develop practical strategies. The role requires strong project management, communication skills, and the ability to work independently in a client-facing

Qualifications

• Bachelor’s or Master’s degree in a related discipline.
• Strong experience in Regulatory Affairs CMC and product development.
• Familiarity with CTD Modules 2.3 and 3 and CMC submission docs.
• Knowledge of global regulatory requirements for pharmaceutical CMC.
• Experience in new product development and lifecycle management.
• Excellent cross-functional collaboration and communication.

Responsibilities

• Lead or support Regulatory CMC strategy for new product development and lifecycle programs.
• Provide CMC regulatory guidance for pharmaceutical and self-care products globally.
• Develop, review, and maintain CTD Module 2.3 and 3 documentation.
• Prepare and review CMC content for regulatory submissions.
• Assess CMC changes for regulatory impact and submission requirements.
• Advise on manufacturing, formulation, analytical methods, specifications, and stability.
• Serve as CMC representative on cross-functional teams.
• Coordinate with R&D, Manufacturing, Quality, Supply Chain, and Regulatory colleagues.
• Support regulatory agency interactions and responses on CMC queries.
• Manage regulatory risks and mitigation strategies.
• Ensure ongoing compliance and successful implementation of CMC changes.
• Contribute to process improvements and practical CMC ways of working.

Skills

Regulatory CMC strategy

Pharmaceutical product development

CTD Modules 2.3 and 3

Regulatory submissions

Cross-functional leadership

Project management

Education

Bachelor’s or Master’s in Pharmacy/Pharmaceutical Sciences/Chemistry/Life Sciences

Job description

ClinChoice is seeking an experienced Regulatory Affairs CMC Consultant for a 12-month contract with extension potential. You will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global submissions.

Collaborate with Regulatory Affairs, R&D, Quality, and Supply Chain to develop practical strategies. The role requires strong project management, communication skills, and the ability to work independently in a client-facing