Senior Product Manager, Regulatory Medical Programs

Goldbelt, Inc.; Maryland; Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Paid time off and professional dev.

Job summary

Goldbelt Apex seeks a Senior Product Management Support I to assist in managing therapeutics, diagnostics, and clinical protocols within a regulatory framework. The role involves coordinating FDA/IRB activities and leading cross-functional teams to ensure alignment with IND protocols and regulatory documentation.

The successful candidate will contribute to IND product accountability, protocol management, and related technical reports, while engaging stakeholders across the organization.

Qualifications

• Regulatory documentation and IND protocol management.
• Experience with FDA-regulated products and clinical programs.
• Clinical project and program management across cross-functional teams.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop and review regulatory documentation.
• Coordinate FDA/IRB activities.
• Participate in and lead IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, training, and stakeholder coordination.

Skills

Regulatory documentation

IND protocols

Clinical project management

Cross-functional coordination

FDA-regulated products

Medical product development

Job description

Goldbelt Apex seeks a Senior Product Management Support I to assist in managing therapeutics, diagnostics, and clinical protocols within a regulatory framework. The role involves coordinating FDA/IRB activities and leading cross-functional teams to ensure alignment with IND protocols and regulatory documentation.

The successful candidate will contribute to IND product accountability, protocol management, and related technical reports, while engaging stakeholders across the organization.