Senior Product Manager – Regulatory & Clinical Programs

Goldbelt Apex LLC; Frederick (MD); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Tax-deferred savings options

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex LLC is seeking a Senior Product Management Support I to assist in managing therapeutic, prophylactic, and diagnostic programs and to coordinate regulatory documentation and FDA/IRB activities.

The role requires strong cross-functional collaboration, regulatory knowledge, and hands-on experience in IND protocol management and clinical program coordination. Travel up to 20% may be required, with a competitive salary and benefits package.

Qualifications

• Understanding of cGMP, cGCP, and cGLP in practice.
• Knowledge of FDA requirements and Title 21 CFR for INDs.
• Experience with regulatory documentation and clinical programs.
• Ability to coordinate cross-functional teams across disciplines.

Responsibilities

• Support product/project management for therapeutics, prophylactics, diagnostics, and protocols.
• Develop and review regulatory documentation.
• Coordinate FDA/IRB activities.
• Lead IPTs and working groups.
• Support IND product accountability and protocol management.

Skills

Medical product dev

FDA-regulated programs

IND protocols

Regulatory docs

Clinical project mgmt

Cross-functional coord

Job description

Goldbelt Apex LLC is seeking a Senior Product Management Support I to assist in managing therapeutic, prophylactic, and diagnostic programs and to coordinate regulatory documentation and FDA/IRB activities.

The role requires strong cross-functional collaboration, regulatory knowledge, and hands-on experience in IND protocol management and clinical program coordination. Travel up to 20% may be required, with a competitive salary and benefits package.