Regulatory Affairs – CMC Consultant

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide regulatory CMC expertise to support the client's pharmaceutical and self-care portfolio.

• Lead or assist in developing Regulatory CMC strategies for new product initiatives and lifecycle management programs.

• Offer CMC regulatory guidance for pharmaceutical and self-care products in global markets.

• Create, evaluate, and maintain documentation for CTD Module 2.3 and Module 3.

• Prepare and review CMC content for new applications, variations, and post-approval modifications.

• Evaluate proposed CMC changes for their regulatory implications, compliance, risks, and submission necessities.

• Provide expertise on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC issues.

• Serve as the CMC representative on cross-functional teams focused on product development and lifecycle management.

• Collaborate with R&D, Manufacturing, Quality, Supply Chain, and Regulatory teams to address CMC challenges.

• Assist in interactions with regulatory agencies and respond to CMC-related inquiries.

• Manage regulatory risks and devise mitigation and contingency plans.

• Ensure continuous regulatory compliance and the effective implementation of approved CMC modifications.

• Contribute to process enhancements, simplification efforts, and efficient CMC practices.

⛳️ Requirements

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field.

• Extensive experience in Regulatory Affairs CMC and/or pharmaceutical product development.

• Familiarity with CTD Modules 2.3 and 3 as well as CMC submission documentation.

• Understanding of global regulatory standards pertaining to pharmaceutical CMC.

• Experience in new product development and post-approval lifecycle management.

• Strong grasp of CMC regulatory requirements related to manufacturing, formulation, analytical testing, specifications, and stability.

• Proven ability to work effectively within cross-functional teams.

• Excellent project management, communication, problem-solving, and stakeholder management skills.

• Preferred: experience in supporting OTC, self-care, consumer health, or pharmaceutical products.

• Preferred: experience engaging with multiple global markets and regulatory regions.

• Preferred: experience in liaising with health authorities or addressing regulatory inquiries.

• Preferred: ability to influence cross-functional teams and provide concise, practical regulatory guidance.

🏝️ Benefits

• 12-month contract with the potential for extension.

• Opportunities for professional development.

• A supportive workplace culture.

• Ongoing training initiatives.

• Commitment to equal opportunity and a diversity-focused environment.