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International CMC Regulatory Affairs Associate Director I

Ort Bengaluru, State of Karnataka, Indien Anzeigen-ID R-201332 Veröffentlichungsdatum 11/07/2024

Job Title: International CMC RA Associate Director I

Career Level - E

Introduction to Role:

Join us at AstraZeneca as an International CMC RA Associate Director and play a critical role in impacting patients in need. In this role, you will have the opportunity to utilize your expertise in CMC Regulatory Strategy, Operational, tactical, and decision-making 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.

Accountabilities:

As an International CMC RA Associate Director, you will provide international regulatory CMC knowledge to TA and non-TA projects within International Regulatory Affairs and AZ technical functions. You will ensure project activities meet AZ business requirements, compliance requirements and regulatory authority expectations worldwide. You will define the strategy and content of International CMC submissions and review and approve regulatory CMC documents for assigned projects. You will also facilitate/support CMC related interactions with Health Authorities within the international region and manage high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation.

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's Biopharmaceuticals R&D division, we are committed to turning our drug development strategies into reality. We are a diverse and open-minded team harnessing our different skills and experiences to explore new ideas and ways of doing things. We are part of the solution, involved in key discussions, acting as both a drug developer and Regulator. We constructively challenge each other to think of the best approach and influence external Regulators. We are striving for technology adoption and automation to drive efficiencies and new innovations.

Are you ready to make a difference? Apply today to join our team at AstraZeneca!



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