Manager, Regulatory CMC at AstraZeneca

Posted in Other 7 days ago.

Location: Gaithersburg, Maryland

Job Description:

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

In this role as Regulatory CMC Manager, you will be a part of the AstraZeneca regulatory CMC group. This role leads the execution of clinical trial applications (CTA) of biotechnology products and is considered the regulatory CMC clinical trial specialist in CTA country-specific regulatory CMC requirements for biologics.

Main Responsibilities

  • Accountable for delivering "submission ready" CMC modules to internal and external regulatory partners in compliance with relevant AstraZeneca systems and procedures

  • Responsible for updating and communicating agreed submission timelines to regulatory CMC leads and CMC and GRET teams

  • Works closely with the regulatory CMC lead to ensure the agreed submission strategy is executed and to provide complete CTD CMC module 1 documentation per regional regulatory requirements

  • Participates in the planning, preparation (including authoring) and delivery of CMC submissions

  • Works proactively with Scientific Writing and Scientific Writing Support in the creation and maintenance of Virtual Document in CARA

  • Collaborates with biologics regulatory CMC post-approval team to ensure appropriate transition

  • Partners with appropriate global regulatory functions and external regulatory partners to ensure delivery of CMC files and documentation

  • Contributes to monitoring of regulatory CMC environment on regular basis by assessing clinical trial health agency questions database

  • Authors and/or reviews CMC-relevant information for clinical trial applications such as EUDRA CT Forms, Module 1 Summary of Changes, DSUR, simplified IMPDs and any additional required documentation.

  • Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions

Minimum Requirements

  • BS or MS in Scientific field of study

  • 4+ years of related biopharmaceutical or pharmaceutical industry experience (e.g. analytical development, Quality Control, manufacturing)

  • 2+ years of Regulatory Affairs CMC submissions experience


  • Knowledge of CMC document content and experience with a Documentum based electronic document repository system

  • Ability to interpret, understand and effectively communicate relevant FDA, ICH, RoW regulatory CMC requirements relating to electronic submissions

  • Knowledge of the drug development process

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them