Hiring for Sr. Manager / AGM for Bioequivalence & Biosimilars Clinical Study Operation.

Qualification
M.Pharm (Pharmacology/Pharmaceutics/Clinical Pharmacy or equivalent)

Experience
10 to 15 years of relevant experience in Clinical Research, Biosimilar Development, and Bioequivalence (BE) Studies in the pharmaceutical industry/CRO.
Experience in managing biosimilar clinical development programs and regulatory studies is preferred.

Key Responsibilities
Lead the planning, design, execution, monitoring, and reporting of Biosimilar and Bioequivalence (BE) studies.
Provide scientific and operational expertise for biosimilar development programs, including PK/PD studies, comparative clinical pharmacology studies, confirmatory Phase III efficacy and safety studies, immunogenicity assessments, and other regulatory-required studies.
Design and review clinical study protocols, informed consent documents, CRFs,



and other study-related documents to ensure scientific and regulatory compliance.
Participate actively in study design discussions, protocol development, feasibility assessments, and overall clinical development strategy.
Coordinate with CROs, clinical sites, central laboratories, bioanalytical laboratories, and cross-functional teams to ensure timely and high-quality study execution.
Review study documents, including study plans, monitoring reports, clinical study reports (CSRs), and bioequivalence study reports for scientific accuracy and regulatory compliance.

Required Skills:
Comprehensive knowledge of biosimilar development pathways and regulatory requirements.
Thorough knowledge of ICH-GCP, NDCTR, CDSCO, USFDA, EMA, and other global regulatory requirements applicable to biosimilars and BE studies.

📌 Sr Manager For Bioequivalence & Biosimilar Clinical Study Operation Mumbai
🏢 IPCA
📍 Mumbai