International CMC RA Associate Director

3 weeks ago


bangalore, India AstraZeneca Full time

Job Title: International CMC RA Associate Director.

Career Level - E

Introduction to Role:
Join us at AstraZeneca as an International CMC RA Associate Director. In this role, you will be responsible for providing the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and product ranges from initial filing to post approval lifecycle management. You will represent CMC Regulatory in cross-functional teams across the business and contribute to the development of new guidance, policy, and processes. This is an opportunity to harness diverse knowledge and move with agility in a nimble and agile environment.

Accountabilities:
As an International CMC RA Associate Director, you will provide International regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within International Regulatory Affairs and AZ technical functions. You will ensure project activities are delivered to a high standard, agreed timelines, and meet AZ business requirements, compliance requirements and regulatory authority expectations worldwide. You will also define the strategy and content of International CMC submissions and review and approve regulatory CMC documents for assigned projects. 

Essential Skills/Experience:
- Degree /PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science.
- Breadth of knowledge of manufacturing, project, technical and regulatory management. 
- Understanding of regulatory affairs globally.
- Stakeholder & Project management 
- Professional capabilities: Regulatory knowledge
- Post graduate qualification
- Business, financial and supply chain understanding/ awareness 
- 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
- Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
- Lean Capabilities
- Quality Risk Management 

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next.

Are you ready to be part of the solution? Are you ready to push beyond the traditional? Are you ready to lead breakthroughs? If so, apply today

Date Posted

25-Apr-2024

Closing Date

28-Apr-2024

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