Regulatory Affairs Manager I

Job Title: Regulatory Affairs Manager

Introduction to role:
Are you ready to make a difference in the world of medicine? As a Regulatory Affairs Manager (RAM) at AstraZeneca, you'll be at the forefront of transforming breakthrough science into life-altering solutions. You'll lead the planning, coordination, and execution of regulatory deliverables, contributing to submission strategies and managing applications through approval. Your expertise will guide cross-functional teams, ensuring that our innovative treatments reach patients efficiently and effectively.

Accountabilities:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input 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 of documents (e.g., response documents, study protocols, PSRs, etc.).
•   Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product.
• - Use and share standard methodologies when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Develop, implement, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators.
• -Coordinate the input, maintenance, and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• -Identify regulatory risks and propose mitigations to Lead RPM and cross-functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of GRO, MCs, CROs, and/or alliance partners where relevant.
• Provide coaching, mentoring, and knowledge sharing within the RAM skill group.
• Contribute to process improvement.

Essential Skills/Experience:

• Relevant University Degree in Science or related field
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General 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
• Proficiency with common project management (e.g., MS Project) and document management tools
• 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
• Desirable Skills/Experience:
• Regulatory experience
• Managed regulatory deliverables at the project level
• Thorough knowledge of the drug development process
• Knowledge of AZ Business and processes

Desirable Skills/Experience:

• Regulatory experience
• Managed regulatory deliverables at the project level
• Thorough knowledge of the drug development process
• Knowledge of AZ Business and processes

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 are driven by science, success, and achieving our goals through novel approaches. Our inclusive environment fosters collaboration across global teams, unlocking regulatory knowledge to bring life-changing medicines to patients. With a rich pipeline offering exposure to diverse therapy areas, you'll have opportunities to take on new challenges and drive innovation. Be empowered to be an agent of change in a globally connected business that values learning and sharing best practices.

Ready to make an impact? Apply now to join our team!