Regulatory Affairs Strategy & Submissions Specialist

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) with company matching

Tax-deferred savings options

Supplementary benefits

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role includes preparing regulatory submissions and supporting interactions with FDA and regulatory agencies.

The position emphasizes regulatory risk assessment, lifecycle planning, and collaboration with product managers and cross-functional teams. Travel up to 20% is required.

Qualifications

• In-depth understanding of regulatory requirements across medical product lifecycle.
• Strong understanding of drugs, biologics, blood/blood products, medical devices.
• Strong analytical and problem-solving ability.
• Ability to work independently and collaboratively.
• Travel: Up to 20%.

Responsibilities

• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports.
• Support FDA/regulatory agency interactions.
• Conduct regulatory gap analyses.
• Advise product managers and IPTs on regulatory risk and product lifecycle strategy.

Skills

FDA regulatory affairs

Product lifecycle

Drugs/biologics/devices

Regulatory submissions

Clinical/preclinical

Job description

Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role includes preparing regulatory submissions and supporting interactions with FDA and regulatory agencies.

The position emphasizes regulatory risk assessment, lifecycle planning, and collaboration with product managers and cross-functional teams. Travel up to 20% is required.