Regulatory Affairs – CMC Consultant

🔥 18 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• 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

• 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

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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume