Pharmaceutical ConsultantApsida Life Science • Saint Paul, Illinois, United States
Pharmaceutical Consultant
Apsida Life Science
- Saint Paul, Illinois, United States
- Saint Paul, Illinois, United States
À propos
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: Linda.goba@apsida.com
Website: www.apsida.co.uk
Phone: +44 (0) 744 134 2145
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Compétences linguistiques
- English
Avis aux utilisateurs
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