CMC RA Manager I Submission Excellence
2 weeks ago
Job Title: CMC RA Manager I Submission Excellence & Project Management
Career Level - D
Introduction to role:
Join us at AstraZeneca as a CMC RA Manager I Submission Excellence & Project Management. The role holders project manage all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics and biologics) to deliver the needs of both the AstraZeneca business and the customer, including publishing of clinical and marketing regulatory documents. They project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle.
The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.
They will ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance, policy, and processes.
You will be part of our R&D team, ensuring that project activities and documentation are delivered to the required standards across the product lifecycle. .
Accountabilities:
As a CMC RA Manager, you will manage the timely preparation and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout their lifecycle. You will be accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders, ensuring submission quality. You will also be responsible for documenting maintenance and communication of Health Authority approval status. Your role will involve developing and building expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
Essential Skills/Experience:
University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
Minimum 9 years of Relevant experience from biopharmaceutical industry, or other relevant experience
Breadth of knowledge of manufacturing, project, technical and regulatory management.
IT Skills
Stakeholder & Project management
Professional capabilities: Regulatory knowledge
Desirable Skills/Experience:
Knowledge of the drug development process and regulatory submissions
Understanding of current regulatory CMC requirements
Direct/indirect 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 capabilities
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.
Why AstraZeneca?
At AstraZeneca, we are committed to turning our drug development strategies into reality. We think broadly about patients and what it takes to prevent and treat diseases. We are proactively involved in the strategy, changing the course for approvals and influencing regulators on new technology. 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. We are striving for technology adoption and automation to drive efficiencies and new innovations.
Are you ready to be part of a dynamic team that's empowered to make quick decisions? Are you curious by nature, ready to dig into challenges to get to the core of a solution? If so, apply today and join us in our mission to bring life-changing medicines to patients.
Date Posted
12-Jun-2024Closing Date
18-Jun-2024-
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
4 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
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
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
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...
-
Director - International CMC RA
4 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...
-
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
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
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 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...
-
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...
-
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...
-
Regulatory Professional I
1 month ago
bangalore, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs CMC & Device Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...
-
Regulatory Professional I
5 days ago
bangalore, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs CMC & Device Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...
-
Regulatory Professional I
1 month ago
bangalore, India Novo Nordisk Full timeDepartment: Regulatory Affairs CMC & Device Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you...
-
Associate Manager CMC
2 weeks ago
bangalore, India KENVUE SOLUTIONS INDIA PRIVATE LIMITED Legal Entity Full timeDescription Kenvue is currently recruiting for: Associate Manager, Global Regulatory CMC This position reports into Manager Regulatory Affairs and is based at Bangalore. Who We Are At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic...
-
Associate Manager
3 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 month 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
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...
