CMC Regulatory Affairs Specialist

Job Title: CMC Regulatory Affairs Specialist/Manager Small Molecules Location: Remote Experience: 10+ Years Job Summary We are seeking an experienced CMC Regulatory Affairs professional with expertise in small molecule drug development to support global regulatory submissions and lifecycle management activities. The candidate will be responsible for preparing, reviewing, and managing Chemistry, Manufacturing, and Controls (CMC) regulatory documentation for investigational and marketed products.

Job Title: Regulatory Affairs - Operations Specialist Location: New Jersey, NJ (Remote) Duration: 6-12 Months Job Description: Must Have: Chemistry Manufacturing Controls (CMC) Develop and implement compliance policies and procedures.Monitor and evaluate compliance with regulations and standards.Conduct internal audits to identify compliance issues.Provide guidance and training on regulatory compliance to staff.Coordinate responses to regulatory inquiries and audits.Stay current on regulatory ch

Job Title: CMC Regulatory Affairs Specialist - Small Molecules Location: Remote Job Summary: Responsible for preparing and managing CMC regulatory submissions for small-molecule drug products, ensuring compliance with global regulatory requirements. Key Responsibilities: Prepare and review CMC sections for IND, NDA, ANDA, and MAA submissions Author Module 3 (Quality) documents in eCTD format Ensure compliance with FDA, EMA, Health Canada, and ICH guidelines Support manufacturing, analytic

Job Title: Regulatory Compliance SpecialistLocation: Avenel, New Jersey (Remote)Duration: 1 year Job Description :Responsibilities: Develop and implement compliance policies and procedures. Monitor and evaluate compliance with regulations and standards. Conduct internal audits to identify compliance issues. Provide guidance and training on regulatory compliance to staff. Coordinate responses to regulatory inquiries and audits. Stay current on regulatory changes and industry best practices. Ensur