CMC Regulatory

Summary: The Regulatory Affairs - Operations Specialist role focuses on developing and implementing compliance policies related to Chemistry Manufacturing Controls (CMC). The position involves monitoring compliance with regulations, conducting internal audits, and providing training to staff. The specialist will also coordinate responses to regulatory inquiries and ensure accurate documentation of compliance activities. This is a remote position based in New Jersey, NJ, with a duration of 6-12 months.

Key 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.
• Ensure timely and accurate documentation and reporting of compliance activities.

Key Skills:

• Chemistry Manufacturing Controls (CMC)
• Regulatory compliance knowledge
• Internal auditing skills
• Training and guidance capabilities
• Documentation and reporting proficiency
• Ability to monitor regulatory changes

Salary (Rate): undetermined

City: undetermined

Country: undetermined

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other