Regulatory Affairs – CMC Consultant

ClinChoice•Raritan, NJ

9d•Hybrid

About The Position

ClinChoice is searching for a Regulatory CMC Consultant for a 12-month contract with the possibility of extension to join one of our clients. 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.

Requirements

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.

Nice To Haves

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.

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.