Director, CMC Regulatory

Company: AstraZeneca GmbH
Location: Gaithersburg
Posted on: May 7, 2025

Job Description:

Be trusted and empowered to be the best you can be! Here at AstraZeneca, we thrive in our inclusive and ambitious environment. We draw on our knowledge to take smart risks and uncover creative ways to better deliver for our patients and our business.Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and own the regulatory strategy for the development, manufacturing, and testing of all our medicines. With our expertise, we interpret, anticipate, and craft global Health Authority expectations to build CMC and Device Regulatory Strategies.We are seeking a Director, CMC RA to join our dedicated team in Gaithersburg, MD. Recognizing the importance of individualized flexibility, our work approach allows employees to balance personal and work commitments while fostering a strong culture of collaboration by engaging face-to-face in our offices 3 days a week.What You'll DoIn this role, you will represent CMC Regulatory in cross-functional teams such as Biopharmaceutical Development Project teams, Global Regulatory Strategy Teams, and Clinical Supply Chain/Global Supply Teams. You will lead the development of new guidance, policies, and processes, acting as a key contact for customer functions to facilitate high-quality partnerships internally and externally.The CMC Regulatory Affairs Director will collaborate with other project leads to support complex projects, contribute to and lead regulatory CMC advice, and support business-related projects throughout the product lifecycle, including clinical development, line extensions, and post-marketing management for synthetics and biologics. Effective communication within the project team and direct advising are essential, along with managing risks and ensuring compliance with global CMC regulations and guidance.Responsibilities

• Provide CMC RA expertise across business functions, potentially leading key initiatives and participating in external industry groups.
• Offer operational, tactical, and strategic guidance for CMC submissions across product lifecycle stages.
• Lead interactions with global Health Authorities when necessary.
• Provide expert regulatory strategic guidance for operational initiatives, including complex and accelerated projects.
• Contribute to policy setting and strategy development within or outside AstraZeneca.
• Lead knowledge sharing, coaching, and community practice activities within CMC RA and wider functions.
• Manage high-level risks through complex judgments and innovative solutions.
• Provide clear guidance on current CMC regulatory requirements to support tactical and strategic planning.
• Support implementation of agile approaches in CMC dossier management to enhance flexibility and efficiency.
• Participate in due diligence teams as needed.
• Lead or contribute to cross-SET non-drug projects, ensuring regulatory compliance and supporting launch activities.
• Ensure activities align with company values, ethics, and policies, including SHE standards. Complete all required training and report non-compliance issues.Requirements
  • Bachelor's degree in Science, Regulatory Sciences, or Pharmacy.
  • 7+ years of experience in Regulatory/Drug development (industry or health authority).
  • Knowledge of manufacturing, project, technical, and regulatory project management.
  • Strong understanding of global regulatory affairs.
  • Direct regulatory CMC experience with synthetic and/or biologic products.
  • Stakeholder and project management skills.Desirable Skills/Experience
    • Masters or PhD in related fields.
    • 10+ years of experience in Regulatory/Drug development.
    • Understanding of regulations governing biotech products, especially monoclonal antibodies, antibody-drug conjugates, or radiopharmaceuticals.
    • Experience with regulatory interactions, inspections, and policy advocacy.At AstraZeneca, we are recognized as experts at the forefront of science, making a significant impact. We thrive on responsibility and are committed to helping patients in need. Our environment fosters continuous improvement and innovation, embracing global opportunities across therapy areas to deliver life-changing medicines.Ready to make a difference? Apply today and join our team!The annual base pay for this position ranges from $186,233 to $279,349, with additional benefits including short-term incentives, long-term incentives, retirement contributions, and comprehensive health coverage. Details will be provided upon offer of employment. We reserve the right to modify pay and benefits at any time.
      #J-18808-Ljbffr

Keywords: AstraZeneca GmbH, Burke , Director, CMC Regulatory, Executive , Gaithersburg, Virginia