Regulatory Affairs – CMC Consultant

Location: United States; hybrid

Company

hirify.global is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead or support CMC regulatory strategies for new product development and lifecycle management programs.
• Provide regulatory guidance for pharmaceutical and self-care products across global markets.
• Develop, review, and maintain CTD Modules 2.3 and 3 and CMC submission documentation.
• Assess post-approval CMC changes for regulatory impact, compliance, risks, and submission requirements.
• Advise on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics.
• Partner with R&D, Manufacturing, Quality, Supply Chain, and Regulatory teams to resolve issues, support agency interactions, and implement approved changes.

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 pharmaceutical CMC regulatory requirements, including manufacturing, formulation, analytical testing, specifications, and stability.
• Experience with new product development and post-approval lifecycle management.
• Strong project management, communication, problem-solving, and stakeholder-management skills.

Nice to have

• Experience with OTC, self-care, consumer health, or pharmaceutical products.
• Experience 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 practical regulatory guidance.

Culture & Benefits

• Client-facing role with independent work and close collaboration with client counterparts.
• Access to the security and career opportunities of a global CRO while working directly with a single sponsor.
• Focus on quality, professional development, continuous training, and a supportive culture.
• 12-month contract with possibility of extension.
• Inclusive equal-opportunity environment with diverse teams across more than 20 countries.

Hiring process

• Application acknowledgement is sent after CV submission.
• Selected candidates are invited to a phone interview as the first step.