Senior Compliance Leader, FDA & Contracts

BioLab Holdings, Inc.; North Charleston (SC); Sur place; USD 175 000 - 260 000; Plein temps

Résumé du poste

BioLab Holdings, Inc. in North Charleston, SC seeks a Senior Manager of Compliance to lead regulatory, auditing, monitoring, and contracting functions. You will serve as a trusted legal advisor to executive leadership and manage audits and investigations to ensure alignment with FDA and OIG requirements.

The role requires a JD, active bar membership, and 7+ years of relevant experience in life sciences compliance. Must oversee governance, risk management and regulatory enforcement activities.

Qualifications

• JD from an accredited law school.
• Active bar membership in at least one U.S. jurisdiction.
• 7+ years of combined legal and compliance experience in pharma/medical devices/life sciences.

Responsabilités

• Maintain compliance program aligned with FDA, OIG and regulatory frameworks.
• Design and execute risk-based compliance monitoring and internal audits.
• Draft, review and negotiate commercial contracts (vendor agreements, NDAs, consulting, licensing).

Connaissances

Regulatory compliance

Contract negotiation

FDA/OIG guidance

Formation

Juris Doctor (JD)

Bar membership

Description du poste

BioLab Holdings, Inc. in North Charleston, SC seeks a Senior Manager of Compliance to lead regulatory, auditing, monitoring, and contracting functions. You will serve as a trusted legal advisor to executive leadership and manage audits and investigations to ensure alignment with FDA and OIG requirements.

The role requires a JD, active bar membership, and 7+ years of relevant experience in life sciences compliance. Must oversee governance, risk management and regulatory enforcement activities.