Title: Biosimilar Subject Matter Expert

Location: Argentina (remote)

Duration: 3-6 months

Company Overview

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 Global Regulatory and Technical Operations teams to bridge integral 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 changes in Argentine pharmaceutical legislation, pricing policies, and Health Technology Assessment (HTA) trends via CONETEC.
- Coordinate local Good Manufacturing Practice (GMP) audit readiness and facility certifications (or PIC/S-recognized equivalents) required for commercial batch release in Argentina

Qualifications:
- Advanced degree in a life science discipline (PharmD, PhD, MSc in Biotechnology, Biochemistry, Molecular Biology, or Medicine).
- Minimum of 7–10 years of hands-on experience in the pharmaceutical or biotechnology sector.
- Proven track record of successfully filing, steering, and approving complex biologics or biosimilars through ANMAT.
- Deep understanding of analytical similarity, biological manufacturing processes, and biosimilar development paradigms (ICH Q5E, Q6B, etc.).
- Thorough knowledge of Argentine health authority regulations, local legal representative (MAH) structures, and Spanish-language dossier requirements.

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science: [email protected] www.apsida.co.uk

+44 (0) (phone hidden)

www.apsida.co.uk

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa), dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

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