Regulatory Affairs SME - Drugs, Biologics & Devices

Kapili Services, LLC; Frederick (MD); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401K with company match

Medical insurance

Dental insurance

Disability insurance

Life insurance

Tuition reimbursement

Paid time off

11 paid holidays

Job summary

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government-facing medical solutions at Fort Detrick, Frederick, MD. The role supports preparation of submissions and regulatory strategy within a multi-disciplinary team.

The ideal candidate has 6–8 years of regulatory experience in drugs, biologics, or devices, with strong knowledge of FDA regulations and lifecycle management and the ability to work independently and

Qualifications

• Bachelor's degree required.
• 6–8 years of relevant regulatory experience.
• Expertise in regulatory requirements for drugs, biologics, and devices.
• Strong understanding of FDA regulations and lifecycle management.

Responsibilities

• Provide specialized regulatory guidance and support across product development and lifecycle management.
• Advise on drugs, biologics, and devices; develop regulatory strategies and submissions.
• Support interactions with regulatory agencies and review submission packages.
• Conduct gap analyses against current regulatory requirements.
• Train and mentor team members on regulatory requirements and changes.

Skills

Regulatory affairs

Lifecycle management

Regulatory strategies

Independent work

Cross-functional collaboration

Education

Bachelor's degree

Job description

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government-facing medical solutions at Fort Detrick, Frederick, MD. The role supports preparation of submissions and regulatory strategy within a multi-disciplinary team.

The ideal candidate has 6–8 years of regulatory experience in drugs, biologics, or devices, with strong knowledge of FDA regulations and lifecycle management and the ability to work independently and