Senior Regulatory Affairs Associate,Biologics

Senior Regulatory Affairs Associate ( Biologics ) 4 to 8 years of experience of authoring, compiling and submission of country-specific submission files (MAA, and post-approval changes) of Biologic products in various markets - Regulated (EU/US/Canada) and Emerging Markets. Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective. Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures. Working experience in Regulatory Information Management Systems like Veeva Vault. Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. Strong communications and collaboration skills. Ability to work independently. Show more Show less