Regulatory Affairs Consultant, Biologics
India, Remote求人ID R0000032362 Category Regulatory / Consulting
About this Role
- 7-9 yrs 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.
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