CMC Regulatory Affairs Manager- Submission Excellence and Project Leadership

Gaithersburg, Maryland

This job has expired.

Are you passionate about the application of science to deliver life changing medicines?

Join AstraZeneca, a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associate to join us on a permanent basis in one of our following sites: Gaithersburg (MD), Waltham (MA), South San Francisco (CA), or Mississauga (Canada).

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.

With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.

We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products' throughout the commercial lifecycle; including marketing Authoring Applications (MAAs) and all post approval activities improving the value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and guidance required to advise the development of robust plans for change initiatives.

Being a CMC-RA Manager, means that you will effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle.

As a CMC-RA Manager you will also contribute and own the regulatory CMC components of business-related projects having effective levels of interactive communication with collaborators and project team members to ensure that relevant timelines and regulatory commitments are communicated. The accountabilities also include responsibility for change management as assigned and to ensure the learning from own projects are shared with other co-workers/within the function.

Additionally you will:

  • Be accountable for delivering "submission ready" CMC modules to internal and external regulatory partners in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality
  • Document maintenance and communication of Health Authority approval status
  • Develop and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions
  • Support the agreed strategy to employ fit for purpose content, applying regulatory intelligence to optimize proposed submission content
  • Participate in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team
  • Contribute to business process optimization activities to reduce waste and ensure efficiency
  • Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses and commitments
  • Apply GxP principles according to the stage of product lifecycle

Minimum Qualifications:
  • Bachelor's degree in a scientific subject area or equivalent
  • At least 2 years of proven experience of growing documented success in a biopharmaceutical field or related experience.
  • Breadth of knowledge of manufacturing, project, technical and regulatory management.
  • IT Skills
  • Stakeholder & Project management
  • Regulatory knowledge
  • Project management expertise with the ability to adapt to changing situations to ensure on time delivery

Preferred Qualifications:
  • 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 sophisticated biologic products e.g. vaccines or ATMPs
  • Understanding of regulations and guidance governing the manufacture of biotechnology products
  • Lean capabilities
  • Demonstrated research skills in understanding regulations, and guidance from different regulatory agencies
  • Understands application of appropriate risk management across own activities

Why AstraZeneca

Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows us to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

We explore innovations and confront challenges that others won't, to have a greater impact on patients' lives. We're proud of our pipeline - it's not only changing the face of our industry for good and impacting the lives of patients, it's transforming the careers of our people. We're committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.

What's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Where can I find out more?


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