Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (Biologicals, Vaccines, ) in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.

Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.

Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.

Working knowledge of US, EU, Japan, Canada, Switzerland, Australia regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage

Experience in handling CMC related health authority queries, and author responses to HA reque...