Regulatory Affairs – CMC Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs CMC Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

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.

The successful candidate will partner closely with Regulatory Affairs, R&D, Supply Chain, Quality, and other cross-functional teams to develop and implement effective CMC regulatory strategies.

• 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.

• 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