Regulatory Affairs CMC Specialist

Experteer Overview In this role you drive the preparation and management of CMC dossiers for regulatory submissions worldwide. You work with cross‑functional teams to translate technical reports into submission‑ready Module3 content and assess regulatory impact of changes. You apply GMP, ICH, EMA, and WHO guidelines to ensure compliant technical documentation. You contribute to gap analyses, complex regulatory assessments, and timely regulatory responses, helping bring products to market.

This is a technically focused role at the intersection of science and regulatory strategy, offering meaningful impact on compliance and lifecycle management.

Responsibilities Write and manage Module3 technical sections with relevant departments/functions

Conduct gap analysis to identify documentary/technical gaps in products/processes

Evaluate technical reports (Process Validation Protocols and Reports, Analytical Methods Validation, AMT, Development Reports, TT)
Translate technical reports into regulatory documents suitable for submission to authorities

Assess Module3 for existing products to anticipate future regulatory impact and variations

Perform regulatory assessments for CMC change controls

Qualifications3+ years in regulatory CMC affairs

Strong ability to craft targeted Module3 content

Knowledge of GMP, ICH guidelines, EMA Quality guidelines, WHO guidelines

Experience with interpreting regulatory guidelines for product‑specific contexts
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