Head - Regulatory Affairs - Biologics

RA support to Biotech R&D pipeline and due diligence (product and facility)

Supervise/effect timely filings/approval of dossier

Regulatory compliance of company's assets in Biotechnology R&D pipeline for ROW Markets.

Represent company in various Biotech forums and agency meetings

Sound knowledge of Biotechnology and Regulatory Science

Thorough understanding of regulations and laws governing pharmaceutical business in the country of interest

Capability to envisage issues and resolve them to maintain the flow.

Establish simplified systems to maintain flow through creating regulatory database and knowledge management