2 associate regulatory jobs found for you.

Required Attributes :Bachelor/ master’s degree in a related field (Pharmacy or Chemistry); Diploma in Regulatory Affairs with 5- 10 years Proven experience in regulatory affairs, specifically with US, EU, UK, and Emerging markets. In-depth knowledge of ICH guidelines, ASEAN CTD requirements, and eCTD publishing.  Hands-on experience with regulatory document preparation and review. Strong understanding of QbD principles and ability to analyze trend

Compile, review and submit pre-meeting packages for authority meetings conductrehearsal’s and participate in meetings as appropriate.• Handle Change Requests (CR), Non-conformities (NC) and CAPA cases within areaof responsibility.• Review of Device documentation, protocols and reports within area ofresponsibility. Assess the appropriateness of scientific/technical documentation forspecific regulatory purposes.• Responsible for archiving and retrieving