Regulatory Product Manager – FDA/IND Focus

Goldbelt Apex LLC; Frederick (MD); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company matching

Job summary

Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to oversee regulatory documentation, IND activities, and clinical protocol coordination. The role requires collaboration with IPTs and stakeholders, ensuring compliance with FDA regulations and DoD acquisition processes.

Primary duties include product management support, regulatory documentation development, and leading regulatory coordination efforts with FDA and IRB.

Qualifications

• Knowledge of cGCP, cGLP, cGMP and Title 21 CFR.
• Ability to support IND regulatory requirements.
• Strong technical writing and stakeholder coordination.
• Travel: Up to 20%

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop/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.
• Investigational product/program management.
• FDA/IRB regulatory coordination.
• Clinical protocol management.
• GCP training and regulatory documentation.
• Stakeholder/IPT leadership.
• Product accountability and technical analysis.

Skills

FDA-regulated product development

Investigational products

Clinical protocol management

Regulatory affairs documentation

DoD medical acquisition environment

Job description

Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to oversee regulatory documentation, IND activities, and clinical protocol coordination. The role requires collaboration with IPTs and stakeholders, ensuring compliance with FDA regulations and DoD acquisition processes.

Primary duties include product management support, regulatory documentation development, and leading regulatory coordination efforts with FDA and IRB.