CMC Regulatory Manager

Primary Responsibilities:

• Assisting CMC department in drafting and review of Module 2 and Module 3 documents for IND and NDA submissions
• Assisting CMC department in drafting and review of Cara IMPD documents for CTA submission
• Assist in the preparation for meetings with Regulatory agencies including the FDA
• Assist in the establishment of a rigorous CMC documentation filing system
• Help define long-term CMC Regulatory Strategy for Cara
• Provide regulatory support for clinical supply efforts as needed
• Work closely with Quality Assurance for inspection readiness and cGMP compliance

Qualifications include but not limited to:

• Minimum 10 years’ experience in biotech/pharma
• BS in a science related field.
• Experience writing and review CMC documentation for Regulatory Submissions
• Experience writing and coordination background information to support Regulatory Agency Meetings
• Able to work in collaboratively with internal and external partners
• Ability to operate independently, seeking guidance from Line Management as needed
• Flexible to changing priorities

Primary work location: Stamford, CT

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