CMC Regulatory Affairs Manager - Commercial Biologics (Gaithersburg)
AstraZeneca

Job Info

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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.

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'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 redefining 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.

We are looking for a CMC Regulatory Affairs Manager to join us on a permanent basis at one of our dynamic sites at either Gaithersburg (US), Cambridge (UK), Macclesfield (UK), Sodertalje (Sweden) oureither the UK, US or Sweden.

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 create 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 maximising the value of business critical Supply Chain changes to the AZ organisation by supplying the regulatory context, intelligence and guidance required to inform the development of robust plans for change initiatives.

As a CMC Regulatory Affairs Manager, you will be responsible for strategy and tactical elements of regulatory submissions for approved biologic products and support our biologics manufacturing sites as needed. This role will actively partner with regulatory therapeutic area counterparts to establish alignment with product regulatory strategies and to communicate CMC-RA CB requirements to team members both internally and externally. This position will also be responsible for the development, compilation, and communication of CMC related documents for the life cycle management of biotech and biologic products.

What you'll do:

• Support regulatory representatives on assigned project teams.
• Interacts with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
• Supervises related corporate activities for regulatory compliance regarding manufacturing and development.
• Works with senior CMC-RA management, therapeutic regulatory leads and product team colleagues to develop and research and support implementation of CMC regulatory strategy.
• Coordinate CMC regulatory submissions for assigned products. Lead or support development of all major CTD submission elements relating to CMC and effectively communicate comments/recommendations and proactively engage teams to establish solutions to issues.
• Support interactions with Regulatory Agencies on CMC issues.
• Plans, coordinates, prepares, and supports meetings with regulatory agencies.
• Interprets existing regulations and guidance documents within regulatory department and on project teams.
• Participate and/or lead various multi-disciplinary teams or task-forces related to CMC/product development.
• Interact effectively with external business partners.

Minimum Qualifications:

• BS/MS in a scientific field.
• Proven experience of growing documented success in a biopharmaceutical field.
• Strong understanding of regulations governing manufacture of biotechnology products (e.g. monoclonal antibodies).
• Ability to apply critical thinking skills.
• Excellent oral and written communication skills
• Ability to interpret, understand and effectively communicate all relevant FDA, ICH, and global Regulatory Affairs CMC requirements

Preferred Qualifications

• Experience working with approved biologics, especially vaccines, is preferred.
• Experience with documentation management systems; FirstDoc, Veeva, etc.

Technical experience in the testing or manufacture of biotechnology-derived products or complex biologics

So, 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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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