Lead Consultant-Regulatory Affairs

Responsibilities

Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidances and defined regulatory strategies.
Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
Preparation of Quality Overall Summaries (QOS);
Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
Submission of relevant sections in Annual Reports for US Market.
Preparing RA expert response for deficiency letters from various regulatory authorities;
Assessment of registration documentation for consumer products as per the current Health Authority requirements.
Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
Post-approval submission knowledge for EU markets