Director – CMC Regulatory Affairs (Gene Therapy)

Hi

My name is Karthik Mutyala from Stark Pharma Solutions Inc we are hiring talents for our client. I am working on Director CMC Regulatory Affairs position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Director CMC Regulatory Affairs (Gene Therapy)

Location: Remote (Anywhere in the U.S.)

Were looking for an experienced Director CMC Regulatory Affairs to join a well-funded mid-sized Gene Therapy Biotech organization with a strong pipeline and proven success.

Key Responsibilities

• Lead CMC Regulatory Affairs strategy for gene therapy programs.
• Author and review CMC sections for regulatory submissions (INDs BLAs amendments and global filings).
• Collaborate with CMC Manufacturing Quality and Regulatory teams to ensure compliant submissions.
• Support interactions with regulatory agencies and drive submission readiness.
• Provide strategic regulatory guidance throughout product development and commercialization.

Required Qualifications

• Extensive experience in CMC Regulatory Affairs within the biotechnology or pharmaceutical industry.
• Hands-on experience authoring CMC regulatory content (not just reviewing submissions).
• Strong knowledge of FDA and global regulatory requirements for biologics/gene therapy products.
• Experience supporting INDs BLAs and other regulatory submissions.
• Excellent communication leadership and cross-functional collaboration skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions please send me your updated resume along with the best number and time to reach you.

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Email:

15 Corporate Place S Suite 350

Piscataway New Jersey 08854