Global Regulatory CMC Consultant (Contract)

ClinChoice; New York (NY); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

ClinChoice is seeking a Regulatory Affairs CMC Consultant for a 12-month contract in New York, offering extension potential. The candidate will provide regulatory CMC expertise across product development, lifecycle management, and global submissions.

The role requires strong cross-functional collaboration, experience with CTD Modules 2.3 and 3, and the ability to guide regulatory strategies for pharmaceutical and consumer health products in a global context.

Formación

• Bachelor's or Master's in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Sciences.
• Strong experience in Regulatory Affairs CMC and/or product development.
• Experience with CTD Modules 2.3 and 3 and CMC submission documentation.
• Knowledge of global regulatory requirements for pharmaceutical CMC.
• Experience with product development and lifecycle management.

Responsabilidades

• Lead or support Regulatory CMC strategy for new product development and lifecycle programs.
• Provide CMC regulatory guidance for pharmaceutical and self-care products across global markets.
• Develop, review, and maintain CTD Module 2.3 and Module 3 documentation.
• Prepare and review CMC content for regulatory submissions and post-approval changes.
• Assess regulatory impact, risks, and submission requirements for proposed CMC changes.
• Guide manufacturing, formulation, analytical methods, and stability from a regulatory view.
• Act as CMC representative on cross-functional product teams.
• Collaborate with R&D, Manufacturing, Quality, Supply Chain, Regulatory to resolve CMC issues.
• Support regulatory agency interactions and responses to CMC questions.
• Manage regulatory risks and mitigate where needed; ensure compliant changes.
• Contribute to process improvements and development of CMC ways of working.

Conocimientos

Regulatory CMC

CTD M2.3 & M3

Global regulatory

Product development

Project management

Cross-functional collaboration

Educación

Bachelor's or Master's in Pharmacy/Pharmaceutical Sciences

Descripción del empleo

ClinChoice is seeking a Regulatory Affairs CMC Consultant for a 12-month contract in New York, offering extension potential. The candidate will provide regulatory CMC expertise across product development, lifecycle management, and global submissions.

The role requires strong cross-functional collaboration, experience with CTD Modules 2.3 and 3, and the ability to guide regulatory strategies for pharmaceutical and consumer health products in a global context.