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CMC RA Associate Director Project Leadership

Location Gaithersburg, Maryland, United States Job ID R-198733 Date posted 16/06/2024

CMC RA Associate Director Project Leadership


Are you ready to turn our pipeline into reality and impact unmet patient needs? We are seeking a CMC RA Associate Director Project Leadership to join our Oncology R&D team. The role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and complex product ranges from development phase through to global launch and post approval lifecycle management. You will represent CMC Regulatory as required in cross-functional teams across the business. This is your chance to contribute to the development of new guidance, policy, and processes while acting as a key contact for identified customer functions.

Accountabilities:

As a CMC RA Associate Director Project Leadership, you will provide regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within Global Regulatory Affairs(GRA) and AZ technical functions. You will define the content of CMC submissions and review and approve regulatory CMC documents on behalf of GRA for assigned projects. You will also represent CMC RA on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated. Additionally, you will facilitate/support CMC related interactions with Health Authorities globally and manage the provision of regulatory strategic guidance in support of operational initiatives.

Essential Skills/Experience:

  • - Bachelors degree in Science, Regulatory Sciences or Pharmacy.
  • 1-3 years in a similar role
  • - Breadth of knowledge of manufacturing, project, technical and regulatory management.
  • - Understanding of regulatory affairs globally.
  • - Stakeholder & Project management.
  • - Professional capabilities: Regulatory knowledge.

Desirable Skills/Experience:

  • - Masters degree or PhD in Science, Regulatory Sciences or Pharmacy.
  • - Business, financial and supply chain understanding/ awareness.
  • - Direct Regulatory Affairs CMC experience with submissions for Cell and Gene Therapy product.
  • - Understanding of regulations and guidance governing the manufacture of biotechnology products, especially Cell and Gene Therapy products.
  • - Experience of regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
  • - Lean Capabilities.
  • - Quality Risk Management.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We're motivated by science, success and achieving our goals in a way that's novel and thoughtful. We see change as an opportunity, embracing the possibility to learn, grow and evolve.

Are you ready to be a part of our globally connected business? Apply now!

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 authorization and employment eligibility verification requirements.

50056704 E RGPD

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.