Oncology Regulatory Affairs Specialist

2 weeks ago


Silver Spring, Maryland, United States AE Strategies Full time

Overview of AE Strategies - Our Mission

At AE Strategies, we are dedicated to enhancing cancer treatment through collaboration with researchers, patients, and regulatory bodies. Our focus on public health and patient-centered regulatory practices drives our commitment to ensuring the availability of safe and effective oncological therapies.

Our professionals engage in clinical practice, dedicating up to eight hours weekly to patient care at various oncology centers. This hands-on experience is crucial for maintaining clinical expertise and involves partnerships with leading institutions.

We offer opportunities for career advancement in both research and clinical practice. Many of our team members continue to provide patient care in diverse settings, including academic and community hospitals, while also participating in significant research initiatives. Our contributions to scientific literature are substantial, with numerous publications in prestigious journals.

Position Responsibilities

As a medical officer, your responsibilities will include:

  • Ensuring the safety and efficacy of human drugs marketed across state lines, along with accurate and informative product labeling.
  • Overseeing the safety, potency, and purity of vaccines and biological products.
  • Regulating medical devices to prevent unnecessary exposure to harmful radiation.
  • Conducting thorough inspections and investigations of manufacturing facilities and recommending necessary enforcement actions.

Required Qualifications

Applicants must possess an MD or DO from an accredited institution in the United States or Canada.

Eligibility as a US citizen or Green Card holder is required.

A strong understanding of the regulatory landscape in drug development is essential.



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