Regulatory Affairs Manager - Secondment - 7 months

Regulatory Affairs ManagerJoin us as a Regulatory Affairs Manager (RAM) at AstraZeneca, a science-led enterprise where you can play a critical role in impacting patients in need. The RAM will be a regulatory specialist with project management capabilities, leading the end-to-end planning, coordination, and execution of assigned deliverables. You will contribute to regulatory submission strategy, identify submission risks and opportunities, and manage procedures through approval.Accountabilities:Understand the regulatory framework 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).Lead and contribute to the planning, preparation, and delivery of simple and complex submissions throughout the product’s life cycle.Develop, execute and maintain submission delivery plans, provide status updates to stakeholders, and identify regulatory risks.Essential Skills/Experience:Relevant Bachelors Degree in Science or related disciplineRegulatory experience within the biopharmaceutical industry, or at a health authorityGeneral knowledge of drug developmentStrong project management skillsLeadership skills, including experience leading multi-disciplinary project teamsExcellent written and verbal communication skillsCultural awarenessScientific knowledge sufficient to understand regulatory issuesProficiency with common project management and document management toolsAbility to work independently and as part of a teamInfluencing and stakeholder management skillsAbility to analyze problems and recommend actionsContinuous Improvement and knowledge sharing focusedDesirable Skills/Experience:Regulatory experienceManaged regulatory deliverables at the project levelThorough knowledge of the drug development processKnowledge of AZ Business and processesAt AstraZeneca's Biopharmaceuticals R&D division, we are committed to turning our drug development strategies into reality. We are always looking for someone different to join our efficient and nimble team. If you can offer us some original thinking, a different approach or skillset, then you'll fit in. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next!Are you ready to be part of the solution, involved in key discussions, in our role we act as both a drug developer and Regulator? Are you ready to constructively challenge, pushing each other to think of the best approach and influencing external Regulators? If yes, apply now!Date Posted:

11-Sep-2024Closing Date:

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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