CMC Regulatory Affairs Associate Director
3 weeks ago
Would you like to apply your Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines for products in development? Then AstraZeneca might be the company for you
At AstraZeneca, we do this with the upmost integrity because we are committed to doing the right thing We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe.
Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients.
The CMC RA Associate Director Submission Excellence & Project Manager will use their operational and strategic expertise to support submissions from development through initial marketing authorizations.
The incumbent will manage complex submissions across the oncology portfolio and deliver compliant innovative risk based regulatory strategies for submissions. The incumbent will be a subject matter expert for global CMC regulations, guidance, and lead/contribute to development of new guidance, policies, and processes.
They will proactively collaborate with CMC Product leads, internal and external stakeholders, plan and prioritize deliverables to meet critical timelines for submissions. The incumbent will demonstrate strong project management and tactical delivery expertise to ensure project activities and documentation are delivered to the required standards and timelines.
Your responsibilities include, but are not limited to:
Manage timely preparation and delivery of CMC contributions for global regulatory submissions, amendments, agency queries, and annual reporting for products in development and initial marketing authorization applications. Manage complex global CMC regulatory programs ensuring that project activities and documentation are delivered to agreed timelines, meet business requirements, and compliance with various Health Authority requirements. Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality. Apply GxP principles according to product lifecycle of the drugs. Responsible for performing regulatory change management assessments, as assigned. Participate in regulatory execution and delivery meetings, communicate and provide relevant updates as a CMC RA representative across projects team. Lead /contribute to cross functional non-drug projects teams and may act as business owner for CMC RA related processes , process improvement, lean and simplification activities, including writing/editing processes. Able to apply appropriate level of risk management across activities. Act as Subject Matter Expert (SME) provide coaching, mentoring and knowledge sharingMinimum Qualifications:
Bachelor’s degree in science related field with at least 3 years of Regulatory submission strategy knowledge/experience. Direct Regulatory Affairs CMC experience with submissions for biologics and biotechnology derived products Understanding of regulations and guidance governing the manufacture of biotechnology products Good breadth of knowledge of manufacturing, project, technical and regulatory management. Ability to interpret, understand, and effectively communicate various global regulatory requirements. Stakeholder & Project management experience with the ability to adapt to changing situations to ensure timely delivery of submissions.Desirable Qualifications:
Bachelor’s degree in science related field with at least 7 years of Regulatory strategy knowledge/experience. Experience with Veeva Vault platforms Experience:Mentoring and CoachingLean methodologiesQuality and Compliance ManagementQuality Risk ManagementWhy 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 cutting edge methods, and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn
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Date Posted
13-Jun-2024Closing Date
26-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.-
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