Regulatory Affairs Manager - Secondment - 7 months
Gaithersburg, MD
Employer: | AstraZeneca |
Job Type: | Full Time |
Description | |
Regulatory Affairs Manager Join 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: As a RAM, you will understand the regulatory framework for various types of applications and procedures for small and large molecules across all regions. You will provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s). You will lead and contribute to the planning, preparation, and delivery of simple and complex submissions throughout the product's life cycle. You will also develop, execute and maintain submission delivery plans, provide status updates to stakeholders, and identify regulatory risks. Essential Skills/Experience:
At 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! 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. |