Get new similar jobs by email for
Regulatory Documentation Manag...
or SWE, Molndal
Reporting to the Associate Director/ Group Manager, RDM, the Regulatory Documentation Manager (RDM) is responsible for working with Clinical and Regulatory to build and deliver the Clinical modules for eCTD submissions and monthly investigator updates (routine submissions) to the regulatory authorities (e.g., INDs, IND AEs, CTAs, MAAs, NDAs, sNDAs, Patient Safety documents, protocols, and drug shipments.)
RDM staff provide authoring support to Clinical Development staff and ensures all Clinical deliverables are published to agreed standards, often to challenging deadlines given the nature of safety and regulatory reporting requirements.
RDM staff are experts in understanding regulatory authority requirements on technical/format aspects, for delivery of submissions worldwide. It is imperative that all deliverables meet the strict technical standards imposed upon the pharmaceutical industry by FDA, EMEA and other Health Authorities.
Must have an in depth knowledge of relevant systems used for clinical information and submission handling.
Impact on Business results
What is the global remit? (how many countries will the role operate in?)
Key Relationships to reach solutions
Internal (to AZ or team)
External (to AZ)
|Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation|
Choose a career in the company that will make a meaningful difference in your life. One that will forge a connection between you, those you work with, and the millions of patients across the globe who are the inspiration behind our passion.
We are AstraZeneca. More than 57,000 employees strong, we have a presence in over 100 countries across six continents. We represent a diverse gathering of cultures. Yet there is one element that connects us all: helping people live healthier lives.
Helping people live healthier lives in addition to... Embracing diverse perspectives. Working together to create a better future. These are the common bonds – the catalysts that inspire people to work here. So come here. Arrive knowing there exists the potential to make a real impact. Be among those who continue to make us an innovation-driven company that stands firmly among the world's leaders in biopharmaceuticals.AstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency.