Regulatory Affairs – CMC Consultant

About the role

Regulatory Affairs CMC Consultant for a 12‑month contract with possibility of extension, supporting a client's pharmaceutical and self‑care portfolio. ClinChoice is a global full‑service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high‑quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia‑Pacific. Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly‑qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

Responsibilities

• Lead or support Regulatory CMC strategy for new product development and lifecycle management 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, including new applications, variations, and post‑approval changes.
• Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements.
• Provide regulatory guidance on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics.
• Act as the CMC representative on cross‑functional product development and lifecycle management teams.
• Partner with R&D, Manufacturing, Quality, Supply Chain, and Regulatory colleagues to resolve CMC issues and develop practical regulatory strategies.
• Support regulatory agency interactions and responses to CMC‑related questions, as required.
• Manage regulatory risks and develop appropriate mitigation and contingency strategies.