Regulatory Affairs Manager - Secondment - 7 months at AstraZeneca in Gaithersburg, Maryland

Job 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:

• Relevant Bachelors Degree in Science or related discipline


• Regulatory experience within the biopharmaceutical industry, or at a health authority


• 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


• Proficiency with common project management 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

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. Apply Now