Associate Regulatory Affairs Director

Accountabilities

• Lead and/or contribute to the planning, preparation, and delivery of both simple and complex submissions throughout the product’s life cycle.
• Drive and lead delivery-focused teams, e.g., GRET (Global Regulatory Execution Team) on a product level or RSDT (Regulatory Submission Delivery Team) for major submissions (MAA/NDA).
• Assume overall accountability for the planning, forecasting, and reporting, applying refined project and stakeholder management skills, ensuring optimized delivery of regulatory activities to time and quality.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
  Submission delivery strategy of all dossiers and all application types per market and/or region.
• Review documents and provide regulatory input (e.g., response documents, high-level documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product.
• Identify regulatory risks, opportunities, and proactively develop mitigation strategies for operational regulatory activities, e.g., planned submissions (with input from all team members).
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• As a member of the Regulatory Affairs Manager community, the ARAD will be a recognized expert in the current regulatory environment, understand the regulatory framework, including regional trends for various types of applications, procedures, and documents, in both small and large molecules with a particular focus on planning, delivery, and project management. Provide coaching, mentoring, and knowledge sharing within the RAM skill group.
  
  Contribute to process improvement.

• Bachelor’s degree in science or a related field with 5+ years of regulatory experience within the biopharmaceutical industry or health authority.
• Thorough knowledge of drug development.
• Strong project management skills.
• Leadership skills, including experience leading multi-disciplinary project teams.
• Excellent written and verbal communication skills.
• Cultural awareness.
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.
• Ability to work independently and as part of a team.
• Influencing and stakeholder management skills.
• Ability to analyze problems and recommend actions.
• Continuous improvement and knowledge sharing focused.

• Proficiency with common project management (e.g., MS Project) document management tools and Veeva Vault/ERV.
• Managed complex regulatory deliverables across projects/products.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

The annual base pay (or hourly rate of compensation) for this position ranges from  -  USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the…