Regulatory Affairs – CMC Consultant

About the Role

We are seeking an experienced Regulatory CMC professional to support Client’s pharmaceutical and self-care portfolio. This role will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global regulatory submissions.

Key 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.
• Ensure ongoing regulatory compliance and successful implementation of approved CMC changes.
• Contribute to process improvements, simplification initiatives, and development of effective CMC ways of working.

Required Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related discipline.
• Strong experience in Regulatory Affairs CMC and/or pharmaceutical product development.
• Experience with CTD Modules 2.3 and 3 and CMC submission documentation.
• Knowledge of global regulatory requirements related to pharmaceutical CMC.
• Experience with new product development and post-approval lifecycle management.
• Strong understanding of CMC regulatory requirements involving manufacturing, formulation, analytical testing, specifications, and stability.
• Experience working effectively with cross-functional teams.
• Strong project management, communication, problem-solving, and stakeholder-management skills.

Preferred Experience

• Experience supporting OTC, self-care, consumer health, or pharmaceutical products.
• Experience working across multiple global markets and regulatory regions.
• Experience interacting with health authorities or supporting responses to regulatory questions.
• Ability to influence cross-functional teams and provide clear, practical regulatory guidance.