International CMC Regulatory Affairs Associate Director I
2 weeks ago
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
Date Posted
05-Jun-2024Closing Date
09-Jun-2024-
bangalore, India AstraZeneca Full timeJob 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...
-
International CMC RA Associate Director
2 months ago
Bangalore, India AstraZeneca Full timeJob 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...
-
International CMC RA Associate Director
2 months ago
bangalore, India AstraZeneca Full timeJob 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...
-
Associate Regulatory Affairs Director I
1 month ago
Bangalore, India AstraZeneca Full timeJob Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business...
-
Associate Regulatory Affairs Director I
1 month ago
bangalore, India AstraZeneca Full timeJob Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and...
-
Director - International CMC RA
2 months ago
Bangalore, India AstraZeneca Full timeJob Title: Director - International CMC RA Career Level - F Introduction to Role: Join us as a Regulatory Affairs Director in our Biopharmaceuticals R&D division. In this role, you will support and coach across CMCRA for products/projects and/or specialist areas. You will have an in-depth understanding of the complexity and challenges required for...
-
Director - International CMC RA
3 weeks ago
bangalore, India AstraZeneca Full timeJob Title: Director - International CMC RA Career Level - F Introduction to Role: Join us as a Regulatory Affairs Director in our Biopharmaceuticals R&D division. In this role, you will support and coach across CMCRA for products/projects and/or specialist areas. You will have an in-depth understanding of the complexity and challenges required...
-
Director - International CMC RA
3 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Director - International CMC RA Career Level - F Introduction to Role: Join us as a Regulatory Affairs Director in our Biopharmaceuticals R&D division. In this role, you will support and coach across CMCRA for products/projects and/or specialist areas. You will have an in-depth understanding of the complexity and challenges required for...
-
Director - International CMC RA
2 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Director - International CMC RA Career Level - F Introduction to Role: Join us as a Regulatory Affairs Director in our Biopharmaceuticals R&D division. In this role, you will support and coach across CMCRA for products/projects and/or specialist areas. You will have an in-depth understanding of the complexity and challenges required for...
-
Director - International CMC RA
2 weeks ago
bangalore, India AstraZeneca Full timeJob Title: Director - International CMC RA Career Level - F Introduction to Role: Join us as a Regulatory Affairs Director in our Biopharmaceuticals R&D division. In this role, you will support and coach across CMCRA for products/projects and/or specialist areas. You will have an in-depth understanding of the complexity and challenges required...
-
Director - International CMC RA
2 months ago
bangalore, India AstraZeneca Full timeJob Title: Director - International CMC RA Career Level - F Introduction to Role: Join us as a Regulatory Affairs Director in our Biopharmaceuticals R&D division. In this role, you will support and coach across CMCRA for products/projects and/or specialist areas. You will have an in-depth understanding of the complexity and challenges required...
-
International CMC RA Director
2 weeks ago
bangalore, India AstraZeneca Full timeJob Title: International CMC RA Director Career Level - F Introduction to Role: Join us as an International CMC RA Director, where you will provide strategic, operational, and tactical expertise for projects and complex product ranges from development phase through to global launch and post-approval lifecycle management. This role is a unique...
-
International CMC RA Director
3 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: International CMC RA Director Career Level - F Introduction to Role: Join us as an International CMC RA Director, where you will provide strategic, operational, and tactical expertise for projects and complex product ranges from development phase through to global launch and post-approval lifecycle management. This role is a unique...
-
International CMC RA Director
2 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: International CMC RA Director Career Level - F Introduction to Role: Join us as an International CMC RA Director, where you will provide strategic, operational, and tactical expertise for projects and complex product ranges from development phase through to global launch and post-approval lifecycle management. This role is a unique...
-
Regulatory Affairs Associate I
3 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Associate I Career Level - C Introduction to Role: Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role is an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory...
-
Associate Manager
2 weeks ago
bangalore, India Elanco Full timeAt Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose...
-
Associate Manager
4 weeks ago
bangalore, India Elanco Full timeAt Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose...
-
Regulatory Affairs Associate I
3 days ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Associate I Career Level - C Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Associate I, where you will play a critical role in impacting patients in need. As a specialist, you will assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in...
-
Analyst –Global CMC Regulatory
4 weeks ago
bangalore, India Elanco Full timeAt Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose...
-
Associate Manager
1 week ago
bangalore, India Elanco Full timeAt Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy...
