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CMC RA Manager I Submission Excellence & Project Management

Ort Bengaluru, State of Karnataka, Indien Anzeigen-ID R-201970 Veröffentlichungsdatum 09/07/2024

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.



50056703 D RGPD

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