Regulatory Affairs Manager, Vaccines & Immune Therapies Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functionally and globally?
At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients' lives. That difference starts with you. We need people who share our passion for science and determination to meet patients' needs around the world. Working here means being ambitious, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative Vaccines and Immune Therapies for the prevention and treatment of Infectious diseases. We are now looking for passionate colleagues to join our Regulatory Project Management team as a Regulatory Affairs Manager (RAM). With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline.
The role is based at AstraZeneca's dynamic R&D site in Barcelona. What you'll do The Regulatory Affairs Manager (RAM) is a global regulatory specialist with project management capabilities responsible for leading / contributing to the end-to-end planning, coordination, and execution of assigned deliverables. The RAM manages delivery of submissions to time, quality, and in compliance with applicable regulations. The RAM is a contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory submissions and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to Regulatory and cross-functional teams working globally to ensure the delivery of business objectives.
Accountabilities/Responsibilities Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).Develop, execute and maintain submission delivery plans, submission content plans, support operational and compliance activities for assigned deliverables and proactively provide status updates to designated stakeholders.Lead and/or contribute to the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.Contribute to Submission delivery strategy.Review documents for compliance with applicable internal policies and regulations (e.g., study protocols, Periodic Safety Reports, etc.).Identify regulatory risks and communicate mitigations to Regulatory lead and cross functional teams.Understand the regulatory framework, including regional trends, for various types of applications and procedures spanning a product's lifecycle for small and large molecules globally.Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.Contribute to process improvement to maintain and continuously improve regulatory consistency.Oversee general Regulatory compliance in assigned markets/regions and escalate any compliance issues.Essential for the role Relevant University Degree in Science or related discipline.Regulatory experience within the biopharmaceutical industry, experience at a health authority, or other relevant experience.General knowledge of drug development.Leadership skills, including experience leading multi-disciplinary project teams.Excellent written and verbal communication skills.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.Desirable for the role Managed regulatory deliverables across projects/products.Detailed knowledge of the drug development process.
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