Regulatory Affairs Consultant - job 1 of 2

Job Summary

A company is looking for a Regulatory Affairs Consultant I to support a global pharmaceutical client in Chemistry, Manufacturing, and Controls (CMC).

Key Responsibilities

• Lead and manage regulatory milestones for assigned products throughout the product lifecycle
• Develop and execute CMC regulatory strategies for post-approval pharmaceutical products in compliance with global regulations
• Author and review global CMC submissions and coordinate responses to regulatory authority questions related to CMC content

Qualifications and Requirements

• Bachelor's or Master's degree in Pharmacy, Biological Sciences, Engineering, or a related field; advanced degree preferred
• Minimum 7 years of experience in CMC post-approval regulatory submissions or related fields
• At least 5 years of experience authoring and reviewing CMC sections in Modules 1, 2, and 3 for post-approval filings
• Strong knowledge of US and European regulatory frameworks and ICH guidelines
• Prior supervisory or team leadership experience is preferred