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:
Website:
Phone: +44 (0)
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