REMS Programs Lead - Compliance & Operations

Amneal Pharmaceuticals; Bridgewater (MA); On-site; USD 140,000 - 155,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a REMS Manager to lead the operational management and oversight of REMS programs within Global Patient Safety. The role ensures REMS programs are implemented in compliance with FDA requirements and company standards in Bridgewater, MA.

You will drive program operations, governance, and KPI reporting, while coordinating with vendors, sponsors, and internal stakeholders. A strong pharmacovigilance background and clear communication skills are essential.

Qualifications

• 3+ years of REMS and pharmacovigilance experience, with at least 2 years in the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Strong REMS, PV Compliance and Pharmacovigilance background.

Responsibilities

• Oversee REMS program operations across the organization and ensure readiness for product launches requiring REMS.
• Represent the company in shared REMS programs and coordinate with stakeholders.
• Lead single-sponsor REMS oversight and monitor program performance and compliance obligations.
• Own REMS operational metrics and KPI reporting with dashboards and executive updates.
• Support FDA inspections and internal audits; track CAPAs and remediation activities.
• Manage REMS vendor relationships and governance; communicate program changes to leadership.
• Maintain regulatory awareness and provide REMS training to Amneal teams.

Skills

REMS

Pharmacovigilance

PV Compliance

Leadership

Communication

Education

Bachelor's Degree (BA/BS) Biological Science - Required

Master Degree (MS/MA) Biological Science - Preferred

Job description

Amneal Pharmaceuticals is seeking a REMS Manager to lead the operational management and oversight of REMS programs within Global Patient Safety. The role ensures REMS programs are implemented in compliance with FDA requirements and company standards in Bridgewater, MA.

You will drive program operations, governance, and KPI reporting, while coordinating with vendors, sponsors, and internal stakeholders. A strong pharmacovigilance background and clear communication skills are essential.