Associate Director, CMC Regulatory Affairs

3 weeks ago

Gaithersburg, United States WORK180 USA Full time

Associate Director, CMC Regulatory Affairs

The most difficult thing is the decision to act, the rest is merely tenacity. The role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and sophisticated product ranges from the development phase through to global launch and post-approval lifecycle management. Role holder will represent CMC Regulatory as required in cross-functional teams across the business for example Pharmaceutical Development Project Teams, Global Regulatory Strategy Teams, and Clinical Supply Chain/Global Supply Teams. Contributes to the development of new guidance, policy, and processes. Acts as key contact for identified customer functions to facilitate high-quality partnerships within and to some extent external to AstraZeneca. Collaborate with other Project Leads/disciplines to support key activities on sophisticated projects. The role holders contribute to and lead regulatory CMC components of business-related projects across the life cycle including clinical development, registration activities, line extensions, and CMC post-marketing management for biologic products where appropriate. The role holder will be encouraged to have effective levels of interactive communication within the project team and directly advise and influence those within the team. Will be encouraged to handle risk using evaluative judgments in complicated or novel situations. They will ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to the development of new guidance, policy, and processes. Provide regulatory CMC knowledge and progressively growing levels of expertise to TA and non-TA projects within Global Regulatory Affairs(GRA) and AZ technical functions. Will typically have responsibility for development projects for clinical development/registration activities/line extensions/post-marketing activities. Ensure project activities are delivered to a high standard, within agreed timelines, and meet AZ business requirements, compliance requirements, and regulatory authority expectations worldwide. Define the content of CMC submissions and review and approve regulatory CMC documents on behalf of GRA for assigned projects. Such submissions could include clinical trial applications (IND, CTA, etc), marketing authorization applications (NDA, MAA, JNDA, etc), line extensions, variations, annual reports, or license renewals for marketed products. Working in collaboration with Submission Excellence, ensure the content of submission documentation is aligned with the agreed cross-functional strategy, with appropriate consideration of the desire for subsequent operational flexibility. Represent CMC RA on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated. Ensure effective networks across the business functions including marketing companies manufacturing sites, Quality, and site technical functions as appropriate for assigned projects or products. Contribute to knowledge sharing, e.g., participate/lead a CoP, and provide mentorship both within CMC RA and across appropriate functional areas Facilitate/support CMC-related interactions with Health Authorities globally. Manage the provision of regulatory strategic guidance in support of operational initiatives Handle and communicate high-level risk by making sophisticated judgments, and developing innovative solutions including proactive risk management and mitigation. Provide AZ technical functions with clear, concise guidance on current CMC regulatory requirements to support business tactical strategic planning. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive management and mitigation. Responsibility for change management as assigned. Apply GxP principles according to the stage of the product lifecycle Highlight resource needs for the product as appropriate for effective planning purposes. Lead /contribute to cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities/management of regulatory information, and ensure regulatory compliance on behalf of AZ Responsibility for change management as assigned. Apply GxP principles according to the stage of the product lifecycle Highlight resource needs for the product as appropriate for effective planning purposes. Lead /contribute to cross SET non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities/management of regulatory information, and ensure regulatory compliance on behalf of AZ Minimum Qualifications: Bachelor's degree in Science, Regulatory Sciences, Pharmacy, or related field. 4 years experience in Regulatory/Drug development (Industry or Health Authority) The breadth of knowledge of manufacturing, project, technical, and regulatory management. Understanding of regulatory affairs globally. Stakeholder & Project management Professional capabilities: Regulatory knowledge Desired Qualifications: Master's degree, or PhD in Science, Regulatory Sciences, or Pharmacy. 7 years experience in Regulatory/Drug development (Industry or Health Authority) Business, financial, and supply chain understanding/ awareness Direct Regulatory Affairs CMC experience, ideally in a development environment Experience in handling submissions for biologic products, and ideally for sophisticated biotechnology-derived products such as radioimmunoconjugate antibody-drug conjugates, cell or gene therapies Understanding of regulations and guidance governing the manufacture of biotechnology products Experience in regulatory health authority interactions, inspections, and/or external advocacy/regulatory policy. Lean Capabilities Quality Risk Management If this sounds like the type of organization where you would like to grow your career and make a real difference to patients then we would like to hear from you; apply today 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 recognizing their potential. Join us on our journey of building a new kind of organization 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.

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