Remote Regulatory Affairs Consultant – Biosimilars

Apsida Life Science; United States; A distancia; USD 90.000 - 150.000; A tiempo parcial

Ventajas ofrecidas por este puesto de trabajo

Competitive Compensation

Impactful Work

Work-life Balance

Descripción de la vacante

A leading life science consulting firm is seeking a Pharmaceutical Regulatory Consultant to provide regulatory expertise in drug development. The candidate will be responsible for interpreting FDA requirements, investigating patent expiry timelines, and translating legal frameworks into insights for teams. This fully remote role requires a bachelor’s degree in Life Sciences or Pharmacy and at least 5 years of regulatory affairs experience. Offers competitive compensation and a work-life balance.

Formación

• 5+ years of hands-on experience in regulatory affairs or pharmaceutical policy.
• Knowledge of the BPCI Act and FDA biosimilar guidance.
• Ability to navigate and interpret FDA 'Purple Book' listings.

Responsabilidades

• Interpreting FDA requirements for biosimilarity.
• Investigating patent expiry timelines and filing data.
• Translating complex legal frameworks into actionable insights.

Conocimientos

Regulatory affairs experience

Knowledge of U.S. drug development law

Ability to interpret patent filing data

Educación

Bachelor’s degree in Life Sciences or Pharmacy

Descripción del empleo

A leading life science consulting firm is seeking a Pharmaceutical Regulatory Consultant to provide regulatory expertise in drug development. The candidate will be responsible for interpreting FDA requirements, investigating patent expiry timelines, and translating legal frameworks into insights for teams. This fully remote role requires a bachelor’s degree in Life Sciences or Pharmacy and at least 5 years of regulatory affairs experience. Offers competitive compensation and a work-life balance.