# Associate Regulatory Affairs Director at AstraZeneca

AstraZeneca is hiring an Associate Regulatory Affairs Director. It pays $135k-$203k a year and Level rates it Little AI ●○○○; you can [apply on AstraZeneca](https://jobsbylevel.com/go/92370739-62ab-471c-a523-5fa07ef5281d?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. US - Gaithersburg - MD.

## Details

- Company: [AstraZeneca](https://jobsbylevel.com/companies/astrazeneca)
- AI level: AI Level 1 (score 38 out of 100)
- Location: US - Gaithersburg - MD
- Salary: $135k-$203k
- Posted: November 12, 2026
- Apply: https://jobsbylevel.com/go/92370739-62ab-471c-a523-5fa07ef5281d?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=associate-regulatory-affairs-director-at-astrazeneca-b9a93d

## Description

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As an Associate Regulatory Affairs Director in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies. Description: The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARPD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Accountabilities/Responsibilities: Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions. Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy of all dossiers and all application types per market and /or region Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.) Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective. Lead GRST & GRET sub-teams, i.e. Crossfunctional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative). Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. Coordinate the input, maintenance and revision in the OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager. Identify regulatory risks and communicate mitigations to Lead RPM and cross functional teams. Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/associate-regulatory-affairs-director-at-astrazeneca-b9a93d

Source: https://jobsbylevel.com/jobs/associate-regulatory-affairs-director-at-astrazeneca-b9a93d

## Cite this page

Level. https://jobsbylevel.com/jobs/associate-regulatory-affairs-director-at-astrazeneca-b9a93d.

Get job alerts: https://jobsbylevel.com/newsletter