Skills
Regulatory documentation
cGMP compliance
Audit and inspection support
About the Role
Join our Quality and Regulatory team in Totowa, New Jersey as a Regulatory Affairs Associate. You’ll support the Manager of Regulatory Affairs by helping ensure compliance through inspections, audits, and accurate regulatory documentation.
This role also involves partnering across QA/QC, production, warehouse, engineering, operations, and external regulatory agencies to keep product and drug records current and audit-ready.
Responsibilities
- Assist the Manager of Regulatory Affairs during cGMP, environmental, and related inspections and audits
- Prepare, update, and maintain product and drug documentation and regulatory statements
- Support compliance activities by organizing records and ensuring documentation is accurate and complete
- Coordinate with internal teams to gather information needed for regulatory submissions and responses
- Maintain clear communication with QA/QC, production, engineering, and operational stakeholders
Requirements
- Experience supporting regulatory documentation and compliance activities in a regulated environment
- Strong attention to detail and the ability to maintain organized, audit-ready records
- Effective communication skills for collaborating with cross-functional teams and external agencies
- Familiarity with cGMP expectations and inspection/audit readiness
Benefits
- Full-time, onsite role with an exempt employment structure
- Opportunity to work closely with quality, regulatory, and operational teams
- Supportive environment focused on compliance and continuous improvement
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