Team Member - Regulatory Writing

Job Purpose

Provide support to RA by preparing regulatory medical writing documents for dossier filing and renewal

Accountabilities

I. Preparation of medical writing documents to support of product registration and life cycle globally except for India
II. Provide insights to RA team to support European, WHO, MCC and US regulatory strategy (biowaivers, posology and proposed indication) by comparing country specific product information/guidance
III. Prepare documents as a response to global regulatory/customer queries on submitted dossiers, scientific justification, bio-waiver justifications and regulatory strategy documents
IV. Co-ordinating with cross-functional teams (BD, packaging, RA, PV etc) to reduce query cycle time and improve document quality

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