Apsida Life Science is currently partnering with an organisation dedicated to community-based clinical trials, ensuring excellent standards of participant care and a smooth transition from the hospital to the home in accordance with study protocols, clinical practice regulations, and ICH-GCP requirements.

Responsibilities:
- Design and execute comprehensive regulatory submission pathways for complex biological and biosimilar products under ANMAT guidelines (including comparability frameworks like Prov. 741/2025 and related biopharmaceutical regulations).
- Lead the authoring, compilation, and review of Common Technical Document (CTD) dossiers (Modules 1 through 5), ensuring rigorous alignment with local standards.
- Manage interactions, scientific advice meetings, and deficiency response cycles with ANMAT evaluators.
- Oversee Chemistry, Manufacturing, and Controls (CMC) documentation, ensuring local compliance for drug substance and drug product specifications.

Scientific & Technical Leadership
- Provide expert guidance on analytical characterization,



structural-functional assessments, and biosimilarity exercise data packages.
- Review and interpret complex data regarding reference product sourcing, lot-to-lot variability, and analytical bridging studies.
- Partner with Integral Regulatory and Technical Operations teams to bridge global development programs with Argentine country-specific requirements

Clinical & Medical Interface
- Support Clinical Development and Medical Affairs by assessing local clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity requirements.
- Engage with Key Opinion Leaders (KOLs), scientific societies, and health authorities to build scientific consensus on extrapolation, interchangeability, and the safety/efficacy profile of biosimilars.
- Provide input on Phase III clinical trial design or local bridging/comparability data needs if mandated by ANMAT.

Lifecycle Management & Pharmacovigilance
- Monitor c

📌 Subject Matter Expert (Argentina)
🏢 Apsida Life Science
📍 Argentina