ClinChoice - Regulatory Affairs – CMC Consultant
Requirements
• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related discipline. • Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences • Strong experience in Regulatory Affairs CMC and/or pharmaceutical product development. • Regulatory Affairs CMC and/or pharmaceutical product development • Experience with CTD Modules 2.3 and 3 and CMC submission documentation. • CTD Modules 2.3 and 3 • Knowledge of global regulatory requirements related to pharmaceutical CMC. • Experience with new product development and post-approval lifecycle management. • 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. • Experience supporting OTC, self-care, consumer health, or pharmaceutical products. • 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. • We are looking for someone who combines strong technical CMC expertise with excellent regulatory judgment, communication, and collaboration skills. The ideal candidate will be comfortable working in a global, cross-functional environment and managing multiple CMC programs and priorities. • technical CMC expertise • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for? • 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 Company Ethos • 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. • Regulatory CMC strategy • Provide CMC regulatory guidance for pharmaceutical and self-care products across global markets. • pharmaceutical and self-care products • Develop, review, and maintain CTD Module 2.3 and Module 3 documentation. • CTD Module 2.3 and Module 3 • 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.
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