International CMC Regulatory Affairs Manager I

Overview

Manage the preparation and delivery of Chemistry, Manufacturing and Control (CMC) documentation for international regulatory submissions for designated synthetic and biologic product ranges, project managing submissions across the product lifecycle.

What you'll do

• Manage the timely preparation, including authoring, and delivery of CMC contributions to regulatory submissions for medicinal products throughout marketing authorisation applications and all post-approval activities.
• Deliver submission-ready CMC modules to internal and external regulatory stakeholders in compliance with AstraZeneca systems and procedures, ensuring submission quality.
• Document, maintain and communicate Health Authority approval status.
• Develop and build expertise in regional regulatory requirements to assure compliance of CMC submissions.
• Apply project management expertise, adapting to changing situations to ensure on-time delivery.
• Share learnings from own projects with colleagues and across functions.
• Support the agreed strategy to employ fit-for-purpose content, applying regulatory intelligence and optimising proposed submission content.
• Participate in regulatory execution and delivery meetings and provide relevant updates to the CMC team.
• Contribute to business process optimisation activities to reduce waste and ensure efficiency.
• Continually evolve regulatory expertise through proactive recording and communication of Health Authority interactions, responses and commitments.
• Apply GxP principles according to the stage of the product lifecycle.
• Take responsibility for change management as assigned.
• Apply appropriate risk management across own activities.
• Research regulations and guidance from different regulatory agencies.

What you'll need

• University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
• Minimum 8 years of relevant experience from the biopharmaceutical industry, or other relevant experience.
• Breadth of knowledge of manufacturing, project, technical and regulatory management.
• IT skills.
• Stakeholder and project management.
• Professional capabilities: regulatory knowledge.

Nice to have

• Knowledge of the drug development process and regulatory submissions.
• Understanding of current regulatory CMC requirements.
• Direct/indirect Regulatory Affairs CMC experience with submissions for medicinal products.
• Understanding of regulations and guidance governing the manufacture of medicinal products.
• Lean capabilities.

Details

• Location: Bangalore, India.
• Work mode: a minimum of three days per week from the office.
• Role type: individual contributor for international markets.
• Global career level: D.