Global Regulatory CMC Manager

Global Regulatory CMC Manager (Senior Consultant)

Duration: 12 Months

Max Rate: $50/HR on W2 All inclusive/No Benefits

Position Summary

We are seeking a highly experienced Global Regulatory CMC Manager (Senior Consultant) to support global Chemistry, Manufacturing & Controls (CMC) regulatory activities across clinical and commercial products. This individual will play a key role in developing regulatory strategies, preparing global submissions, managing product lifecycle changes, and collaborating with cross-functional teams to ensure compliance with global health authority requirements.

The ideal candidate will have extensive experience supporting global regulatory submissions for pharmaceutical and biotechnology products and possess strong knowledge of FDA, EMA, and ICH regulatory requirements.

Key Responsibilities

• Develop and execute global CMC regulatory strategies for clinical and commercial products.
• Prepare, author, review, and submit CMC sections for global regulatory submissions, including:
• INDs
• CTAs
• NDAs
• BLAs
• MAAs
• Prepare health authority briefing documents, scientific advice packages, and responses to regulatory agency questions.
• Support post-approval lifecycle management activities, including regulatory variations, supplements, and change controls.
• Assess regulatory impact of manufacturing, process, and quality changes using electronic quality systems such as Veeva, Verity, Infinity, or eQRMS.
• Ensure all regulatory documentation complies with FDA, EMA, ICH, and other applicable global regulations.
• Partner with Manufacturing, Quality, Analytical Development, Supply Chain, Clinical, and Regulatory teams to drive successful regulatory outcomes.
• Support global health authority interactions, including preparation for FDA, EMA, and other regulatory meetings.
• Manage multiple regulatory projects while identifying risks, proposing mitigation strategies, and ensuring timely deliverables.
• Stay current with evolving global CMC regulations and contribute to continuous process improvements.

Required Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmacy, Chemical Engineering, or another scientific discipline.
• Master's or PhD preferred.
• 10-15 years of experience within the pharmaceutical or biotechnology industry.
• Minimum 5-7 years of hands-on Regulatory CMC experience supporting clinical and/or commercial products.
• Demonstrated experience with global regulatory submissions and post-approval lifecycle management.

Required Skills

• Strong knowledge of global CMC regulatory requirements, including FDA, EMA, and ICH guidelines.
• Hands-on experience preparing and supporting:
• INDs
• CTAs
• NDAs
• BLAs
• MAAs
• Regulatory variations and supplements
• Health authority responses
• Strong understanding of the drug development lifecycle from early development through commercialization.
• Experience with electronic quality/change management systems such as Veeva, Verity, Infinity, or eQRMS.
• Excellent project management, analytical, communication, and stakeholder management skills.
• Ability to work independently in cross-functional global teams.

Preferred Qualifications

• Experience supporting biologics and/or cell & gene therapy products.
• Experience interacting with global regulatory agencies, including FDA, EMA, and PMDA.
• Experience supporting both clinical-stage and commercial products.