Mirrai Careers

Regulatory Affairs – CMC Consultant

ClinChoice

United States Posted 7d ago
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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.   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. 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. 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. What You’ll Bring 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. * 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?   ABOUT CLINCHOICE     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. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-PB1 #LI-Hybrid #Contract

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