Regulatory Affairs Program Lead - Vaccines & IND Strategy

GAP SOLUTIONS INC; Bethesda (MD); On-site; USD 110,000 - 125,000; Full time

Job summary

GAP SOLUTIONS INC is seeking a Scientific Program Manager at the National Institutes of Health (NIH) in Bethesda, MD. The role involves overseeing regulatory affairs related to vaccines and ensuring compliance with FDA regulations. Ideal candidates will possess a Master’s degree and 8-10 years of relevant experience in the field.

The position requires strong communication and project management skills, as well as expertise in regulatory affairs, making this an impactful and essential role within NIH.

Qualifications

• Master’s degree in Biology or similar field of study.
• Minimum of 8-10 years of experience in regulatory affairs related to vaccines.
• Expert knowledge of the relationship of clinical research and regulatory agencies.

Responsibilities

• Manage an Investigational New Drug (IND) application portfolio.
• Serve as an expert on regulatory matters concerning vaccine development.
• Write and review documentation to ensure compliance with FDA regulations.

Skills

Regulatory affairs management

Strong communication skills

Project management

Knowledge of FDA regulations

Education

Master’s degree in Biology or similar field

Tools

Microsoft Office Suite

Job description

GAP SOLUTIONS INC is seeking a Scientific Program Manager at the National Institutes of Health (NIH) in Bethesda, MD. The role involves overseeing regulatory affairs related to vaccines and ensuring compliance with FDA regulations. Ideal candidates will possess a Master’s degree and 8-10 years of relevant experience in the field.

The position requires strong communication and project management skills, as well as expertise in regulatory affairs, making this an impactful and essential role within NIH.