Regulatory Affairs – CMC Consultant

ClinChoice

. Support the client’s pharmaceutical and self-care portfolio with regulatory CMC expertise .

Posted 11/4/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory CMC strategy, including the development and maintenance of CTD Modules 2.3 and 3 documentation, while ensuring compliance with global regulatory requirements. Proven ability to collaborate with cross-functional teams and manage regulatory risks effectively.

Highest-signal resume keywords

Regulatory Affairs CMCCTD Modules 2.3 And 3Pharmaceutical Product DevelopmentCross-Functional Team CollaborationProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMC ExpertiseCTD DocumentationCMC Submission DocumentationManufacturing KnowledgeFormulation KnowledgeAnalytical Testing KnowledgeSpecifications KnowledgeStability KnowledgeRisk AssessmentRegulatory Compliance

Soft Skills

Communication SkillsProblem-Solving SkillsStakeholder ManagementInfluencing Skills

Industry Keywords

PharmaceuticalSelf-CareOTC ProductsConsumer HealthGlobal Regulatory RequirementsLifecycle ManagementHealth Authorities Interaction

About the role

Key responsibilities & impact

Support the client’s pharmaceutical and self-care portfolio with regulatory CMC expertise
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 new applications, variations, and post-approval changes
Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements
Provide guidance on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics
Act as 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
Support regulatory agency interactions and responses to CMC-related questions
Manage regulatory risks and develop mitigation and contingency strategies
Ensure ongoing regulatory compliance and implementation of approved CMC changes
Contribute to process improvements, simplification initiatives, and effective CMC ways of working

Requirements

What you’ll need

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

Benefits

Comp & perks

12 months contract with possibility of extension
Professional development
Supportive culture
Continuous training
Equal opportunity and diversity-focused workplace