Global Regulatory CMC Consultant for Pharma

ClinChoice; New Jersey; Presencial; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

ClinChoice is seeking an experienced Regulatory CMC Consultant for a 12-month contract to support a client in the pharma sector. The role will require independent work, strong regulatory judgment, and collaboration with cross-functional teams.

The ideal candidate will lead CMC strategy across new product development, lifecycle management, post-approval changes, and global submissions, partnering with Regulatory Affairs, Manufacturing, Quality, and R&D.

Formación

• Degree in pharmaceutical sciences or life sciences is required.
• Solid experience in Regulatory Affairs CMC and product development.
• Familiarity with CTD Modules 2.3 and 3 and submission documentation.
• Knowledge of global regulatory requirements for pharmaceutical CMC.

Responsabilidades

• Lead or support Regulatory CMC strategy for development and lifecycle programs.
• Provide CMC regulatory guidance across global markets for products.
• Develop, review and maintain CTD Module 2.3 and Module 3 documentation.
• Prepare and review CMC content for regulatory submissions and changes.
• Assess regulatory impact, risks, and submission requirements for CMC changes.
• Guide manufacturing, formulation, analytical methods, and stability topics.
• Act as CMC representative on cross-functional teams.

Conocimientos

Regulatory CMC

Global submissions

CTD 2.3 & 3

Regulatory strategy

Cross-functional work

Project management

Regulatory guidance

Pharmaceutical development

Educación

Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences

Descripción del empleo

ClinChoice is seeking an experienced Regulatory CMC Consultant for a 12-month contract to support a client in the pharma sector. The role will require independent work, strong regulatory judgment, and collaboration with cross-functional teams.

The ideal candidate will lead CMC strategy across new product development, lifecycle management, post-approval changes, and global submissions, partnering with Regulatory Affairs, Manufacturing, Quality, and R&D.