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Job Title: CMC RA Associate Director I Submission Excellence & Project Management
📍India – Bangalore
Career Level – E
Introduction to role:
Join us at AstraZeneca as a CMC RA Associate Director I Submission Excellence & Project Management. This role is a unique opportunity to manage projects or complex product ranges across the portfolio throughout the product lifecycle. You will be accountable for interfaces with CMC Product leads, proactively partnering with stakeholders across AZ organisation to help deliver and implement innovative risk-based regulatory strategies. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards and timelines.
Accountabilities:
You will be responsible for managing the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle. This includes leading CMC submission management teams, applying project management expertise, highlighting resource needs for product as appropriate for effective planning purposes, and leading/contributing to cross SET non-drug projects. You will also participate in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team.
Essential Skills/Experience:
- University Degree or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.
- Minimum 13 years of Relevant experience from biopharmaceutical industry, or other relevant experience
- Breadth of knowledge of manufacturing, project, technical and regulatory management.
- Strong understanding of regulatory affairs globally
- Stakeholder & Project management
- Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or complex biologic products
- Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
- Lean capability
- Quality Risk Management
- Experience managing resource requirements for pivotal projects.
Date Posted: 17-Jul-2024
Closing Date: 31-Jul-2024
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