Skills
Regulatory compliance
cGMP inspections
Regulatory submissions and facility registrations
About the Role
We’re seeking a Regulatory Affairs Manager to lead site regulatory operations in alignment with global regulatory strategy and corporate quality expectations. Based onsite in Totowa, NJ, you’ll serve as the primary regulatory partner for operational execution at the facility and help ensure clear communication with global quality leadership.
Responsibilities
- Coordinate preparation for regulatory inspections, cGMP audits, and environmental audits, including timely responses and follow-ups.
- Oversee regulatory compliance activities such as submissions support and facility registrations.
- Ensure site adherence to applicable global regulations through effective regulatory oversight and documentation.
- Partner across functions to support inspection readiness and maintain strong execution of regulatory requirements.
- Act as the key regulatory point of contact between site teams and global quality leadership.
Requirements
- Experience in regulatory affairs within a quality-focused environment (e.g., cGMP-regulated setting).
- Strong understanding of regulatory compliance, inspection processes, and audit readiness.
- Ability to manage cross-functional coordination and communicate effectively with internal stakeholders.
- Demonstrated attention to detail and capability to drive timely, compliant responses.
Benefits
- Full-time exempt position with onsite work in Totowa, NJ.
- Opportunity to influence site regulatory execution and support global quality alignment.
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