Associate Regulatory Affairs Director

Company: AstraZeneca
Location: Montgomery Village
Posted on: March 27, 2026

Job 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 ARAD 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. Cross functional 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 Planit 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 partners where relevant. May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies. Provide coaching, mentoring and knowledge sharing within the RAM skill group. Contribute to process improvement. When assigned Lead RPM role ARAD, responsibilities to include: Lead the GRET (Global Regulatory Execution Team). Overall accountability for the project management of all GRET deliverables. Key member of the Global Regulatory Strategy Team (GRST) with focus to deliver the GRST product plan submission milestones. This is achieved by development and execution of operationally efficient submission delivery plans by GRST and GRET members. Identify regulatory risks and risk mitigation strategies for GRET executions and deliverables (with input from all team members). Drive the GRST and GRET resourcing process. Supports Fee forecasting activities. Allocate RAM resources to the GRET deliverables. Liaise with GPM and other functional project managers. Knowledge sharing and RAM development; the go-to person for RAM project guidance and support, provides and facilitates coaching within/between the GRET and GRST. When assigned Market Contact role ARAD, responsibilities to include: Develop, maintain and provide RAM with clear, concise, timely guidance on current priorities and regulatory requirements for assigned market/region(s) to support RAM project deliverables and business tactical/strategic decision-making. Drive market/region knowledge sharing with key stakeholders (e.g. Marketing Companies, Regulatory Skill Groups, CMC Regulatory Compliance) through appropriate meetings, networking and communications. Provide support across RAM to maintain and continuously improve regulatory consistency and to achieve right first time submissions in assigned market/region(s). Proactively develop close relationships and have appropriate levels of interactive communication with Marketing Company staff for assigned market/region(s) to drive effective 2-way sharing of information and interpretation of regulatory requirements relating to RAM deliverables. Coordinate gathering of documentation to support tenders. Oversee general Regulatory compliance in assigned markets/regions and escalate any compliance issues. Minimum Requirements: Bachelor’s degree in science or a related field with 4 years of regulatory experience Relevant University Degree in Science or related discipline Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority Thorough Knowledge of drug development Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams Preferred Requirements: Masters degree in science or a related field with 7 years of experience in regulatory experience Managed first wave Marketing Application and/or LCM submissions Managed complex regulatory deliverables across projects/products Knowledge of AZ Business and processes When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZenecas Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency, objectivity, and ethics drives us to meet unmet medical needs. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives. Ready to make a difference? Apply now! The annual base pay (or hourly rate of compensation) for this position ranges from $135,624.80 - 203,437.20USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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