International CMC Regulatory Affairs Manager I

Overview

International CMC Regulatory Affairs Manager I (Individual Contributor) for international markets, managing Chemistry, Manufacturing and Control (CMC) documentation and regulatory submissions across the product lifecycle.

What you'll do

• Manage timely preparation (including authoring) and delivery of CMC contributions for regulatory submissions across marketing authorisation applications and post-approval activities.
• Project manage international CMC regulatory submissions to deliver required standards across the product lifecycle.
• Deliver “submission ready” CMC modules to internal and external regulatory stakeholders while ensuring submission quality.
• Document and communicate Health Authority approval status for relevant submissions.
• Lead/contribute to regulatory CMC components of business-related projects.
• Participate in regulatory execution and delivery meetings and provide CMC updates.

What you'll need

• 8+ years of relevant experience from the biopharmaceutical industry or other relevant experience.
• University degree in a science or technical field such as pharmacy, biology, chemistry, or biological science.
• Broad knowledge of manufacturing, project, technical, and regulatory management.
• Stakeholder and project management professional capabilities.
• Regulatory knowledge.

Details

• Location: Bangalore, India.
• In-person working: on average, a minimum of three days per week from the office (with flexibility).