Pharmaceutical Consultant

Apsida Life Science; United States; Teletrabalho; USD 90 000 - 150 000; Tempo parcial

Vantagens oferecidas por esta oferta de emprego

Competitive Compensation

Impactful Work

Work-life Balance

Resumo da oferta

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.

Qualificações

• 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.
• Ability to interpret patent filings and FDA Purple Book listings.

Responsabilidades

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

Conhecimentos

Regulatory affairs experience

Knowledge of U.S. drug development law

Ability to interpret patent filing data

Formação académica

Bachelor’s degree in Life Sciences or Pharmacy

Regulatory Affairs degree (PharmD / advanced)

Ferramentas

FDA Purple Book knowledge

Descrição da oferta de emprego

Job Title

Pharmaceutical Regulatory Consultant

Contractual Requirements

Independent Contractor / Freelancer

Fully Remote

Contract Period: 12 months

FTE: 0.4 – 0.6

MUST reside in the USA

Company Overview

Apsida Life Science has partnered with a leading global clinical research organization and biopharmaceutical services provider. They specialize in helping life science companies navigate the complex journey of drug development, offering strategic guidance and regulatory expertise to bring life‑changing therapies to market efficiently and safely.

Key Responsibilities

• Interpreting FDA requirements for biosimilarity.
• Investigating patent expiry timelines, filing data, and the impact of the BPCI Act on market entry.
• Providing targeted insights into the competitive and regulatory environment for Aflibercept biosimilars.
• Translating complex legal and regulatory frameworks into actionable insights for internal teams.

Qualifications

• A bachelor’s degree in Life Sciences (Biology, Chemistry, Biotechnology, etc.), Pharmacy (PharmD), or Regulatory Affairs.
• At least 5 years of hands‑on experience in regulatory affairs or pharmaceutical policy.
• Knowledge of U.S. drug development law, the BPCI Act, and FDA biosimilar guidance.
• Ability to navigate and interpret patent filing data and FDA "Purple Book" listings.

Benefits

• Competitive Compensation
• Impactful Work
• Work‑life Balance

Contact Information

Email: [e-mail]

Website: www.apsida.co.uk

Phone: [phone]