Regulatory Affairs Specialist – Military Medical Solutions

Bering-Alaka'ina Holdings, LLC; Frederick (MD); Presencial; USD 95.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401K plan with company match

medical, dental, disability, and life

tuition reimbursement

paid time off

11 paid holidays

Descripción de la vacante

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Specialist to provide regulatory guidance and support for our government client in Frederick, MD at Fort Detrick. The role covers regulatory strategies, submissions, and interactions with regulatory agencies to ensure compliance across the product lifecycle.

The position requires a Bachelor’s degree and at least four years of relevant experience in drugs, biologics, and medical devices within a military-relevant context.

Formación

• Must hold minimum of Bachelor’s degree.
• Must have minimum of four (4) years’ of relevant experience.
• Must have expertise on relevant regulatory requirements, strategies, and processes regarding product development, submission, and lifecycle management.
• Must have expertise on drugs, biologics, and devices and their application to the development of military-relevant medical solutions.
• Must have a strong understanding of the product development lifecycle and regulatory requirements at each stage.
• Must have an in depth knowledge of development of drugs, biologics, blood and blood products, medical devices, and other medical solutions.
• Must have strong problem-solving and analytical skills.
• Must be able to work independently and as part of a team.

Responsabilidades

• Provide specialized guidance and support and serve as a technical resource with in-depth regulatory expertise for product development and lifecycle management.
• Advise on drugs, biologics, and devices for military-relevant medical solutions; develop and review regulatory strategies and submissions; evaluate regulatory guidelines and policies.
• Support regulatory agency interactions, including meeting preparation, sponsor communications, and management of commitments.
• Conduct gap analyses of existing processes against current regulatory requirements.
• Provide training and mentorship on regulatory requirements and best practices; stay current on regulatory changes.
• Collaborate with R&D, manufacturing, clinical, and marketing to ensure regulatory compliance throughout the product lifecycle.
• Advise product managers and leadership on regulatory risks and opportunities.
• Identify RA strategies to optimize product development across the portfolio.
• Review and analyze clinical summaries, protocols, and safety data to ensure FDA compliance.

Conocimientos

Regulatory requirements

Regulatory strategies

Regulatory submissions

Drugs/biologics/devices

Product lifecycle

Analytical skills

Independent work

Team collaboration

Educación

Bachelor’s degree

Descripción del empleo

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Specialist to provide regulatory guidance and support for our government client in Frederick, MD at Fort Detrick. The role covers regulatory strategies, submissions, and interactions with regulatory agencies to ensure compliance across the product lifecycle.

The position requires a Bachelor’s degree and at least four years of relevant experience in drugs, biologics, and medical devices within a military-relevant context.