Jobs in the United States

25+ jobs

Group jobs by employerEmail me new jobs Save this search

Added 2 mins ago
AA
Director, Quality & Reliability Engineering
Alaska Airlines
WA-SeaTac
- $198,450 to $307,600 USD / year
The Director, Quality & Reliability Engineering sets the long-term strategy and oversees the financial performance of Quality & Reliability Engineering for eCommerce and Digital Experience…
Added 3 mins ago
Associate Director of Student and Alumni Engagement, Panama City Campus
Florida State University
Panama City, FL
…University Advancement is accelerating the hiring of additional development officers’ campus-wide and is excited to build out its team. For Advancement professionals who are interested in…
Added 3 mins ago
Associate Director of Student and Alumni Engagement, College of Arts & Sciences
Florida State University
Tallahassee, FL
…University Advancement is accelerating the hiring of additional development officers’ campus-wide and is excited to build out its team. For Advancement professionals who are interested in…
Added 3 mins ago
ViiV Healthcare (GSK) Global Patient Engagement Director
ViiV Healthcare Company
Remote, United States
The Global Patient Engagement Director – R&D leads the development and execution of ViiV Healthcare’s patient engagement strategy in support of Research and Development, ensuring that…
Added 5 mins ago
Director, Product Management
USAA Federal Savings Bank
Charlotte, NC
As a dedicated Director, Product Management you will manage a team of individual contributors responsible for formulating product/sales strategy recommendations based on analysis of…
Added 6 mins ago
Director, Network Contracting - Pacific Northwest - Cigna Healthcare - Hybrid, Seattle
The Cigna Group
Seattle, WA
The Director, Provider Contracting is an individual contributor role that serves as an integral member of the Provider Contracting Team and reports to the Provider Contracting Senior…
Added 6 mins ago
Director of Sales
Home Place of Burlington
Burlington, NC
Conducts weekly strategy and advisory meetings with the Executive Director.
Added 7 mins ago
Senior Medical Director, Global Safety
Rhythm Pharmaceuticals
Boston, MA
Rhythm is seeking a Senior Medical Director, Global Safety, to provide medical leadership and expertise across the safety of our products throughout development and commercialization. This…
Added 7 mins ago
Director of Catering
Compass Group
Kennett Square, PA
Longwood Gardens is seeking an experienced and collaborative Director of Catering & Events to lead the strategy, growth, and execution of a premier catering and events program. This role…
Added 7 mins ago
Dining Services Director
Compass Group
Monroe Township, NJ
The Director of Dining Services is the strategic business leader of the community’s food and beverage/culinary operation ensuring resident and client satisfaction by providing a…
Added 8 mins ago
Business Development Director - Life Sciences
Welo Global
Remote, United States
We’re seeking a driven, relationship-focused Business Development Director to accelerate growth for Welo Life Sciences, our specialized brand in Life Sciences localization. You’ll open…
Added 9 mins ago
Director, eLearning & Training Management
Insmed Incorporated
United States
Lead the development, implementation, and continuous evolution of the enterprise training strategy, including new hire onboarding, foundational curricula, annual training requirements, and…
Added 9 mins ago
Regional Sales Director, Carolinas
Insmed Incorporated
Eastern North Carolina, NC · Charleston, SC · Greensboro, NC · Durham, NC · Winston-Salem, NC · Charlotte, NC
We’re looking for a Regional Business Director on the Commercial Team team to help us expand what’s possible for patients with serious diseases. Reporting to the Area Sales Director, you’ll…
Added 11 mins ago
Director of Product Marketing
Onto Innovation Inc-US
United States
Directs the development of company market requirements for product(s) or product line(s), including product strategy definition, requirements analysis, and pricing.
Added 11 mins ago
Risk and HSE Director
Hoist & Crane Service Group Inc
New Orleans, LA
This position serves as the senior leader responsible for safety strategy, regulatory compliance, employee training, incident prevention, and continuous improvement of safety performance…
Added 12 mins ago
Director, Peraton[x] Administration and Enablement
Peraton
Remote, United States
Peraton is seeking a Director to lead the administration and user enablement of Peraton[x], our enterprise generative AI and agentic analytics platform. This leader is accountable for how…
Added 13 mins ago
AP
Associate Regulatory Affairs Director
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $135,182.4 to $202,773.6 USD / year
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.…
Added 13 mins ago
A
Associate Director, Biomarker Program Management
AbbVie
Waltham, MA
- $141,500 to $268,500 USD / year
This role can be based in North Chicago, IL, Waltham, MA, or South San Francisco, CA
Added 13 mins ago
A
Associate Director, Biomarker Program Management
AbbVie
San Francisco, CA
- $141,500 to $268,500 USD / year
This role can be based in North Chicago, IL, Waltham, MA, or South San Francisco, CA
Added 13 mins ago
A
Associate Director, Biomarker Program Management
AbbVie
North Chicago, IL
- $141,500 to $268,500 USD / year
This role can be based in North Chicago, IL, Waltham, MA, or South San Francisco, CA
Added 13 mins ago
A
Head of US Commercial Sales Training & Development - AA
AbbVie
Irvine, CA
- $182,000 to $346,000 USD / year
Leadership Development: Strategy and execution of the development of future leadership pipeline at the 1st and 2nd level (Director) level as well as provides development programs for…
Added 13 mins ago
IB
Director, Internal Communications
Ipsen Biopharmaceuticals Inc.
United States
- $177,000 to $259,600 USD / year
The Director, Employee Communications serves as a senior strategic communications advisor to executive leadership, responsible for shaping and leading the company's employee communications…
Added 19 mins ago
LC
Sponsorship Content & Activation Manager (Part-Time)
LINCOLN CENTER
New York, NY
- Part-time
Description: Reporting to the Associate Director, Strategic Partnerships, the Sponsorship Content & Activation Manager (Freelance) will primarily support the Business Development &…
Added 19 mins ago
Senior digital product manager
Starbucks Coffee Company
WA
The senior digital product manager will lead the development of products that transform our end-to-end supply chain from manufacturing and sourcing to logistics, fulfillment, and store…
Added 19 mins ago
Brand manager I, Global Coffee Alliance
Starbucks Coffee Company
WA
Lead near-in innovation and product pipeline development, including seasonal offerings and product or packaging changes, translating consumer and business opportunities into initiatives…

AstraZeneca

Associate Regulatory Affairs Director

Gaithersburg, MD, United States
Gaithersburg, United States

$135,182.4 to $202,773.6 USD / year

Apply on astrazeneca.eightfold.ai About employer

Applications open in a new tab.

Job details

Pay: $135,182.4 to $202,773.6 USD / year
Apply by: May 11, 2027
Experience: Bachelor Degree and 3+ years experience or Masters Degree and 1+ years experience
Posting language: English
Posted: Nov 12, 2026

Original job 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 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 RPM skill group.
Contribute to process improvement.
When assigned Lead RPM role ARPD, 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.
AllocateRPM resources to the GRET deliverables.
Liaise with GPM and other functional project managers.
Knowledge sharing and RPM development; the go-to person for RPM project guidance and support, provides and facilitates coaching within/between the GRET and GRST.

Minimum Requirements –Education and Experience

Bachelor Degree and 3+ years experience or Masters Degree and 1+ years experience
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 Experience

Managed first wave Marketing Application and/or LCM submissions
Managed complex regulatory deliverables across projects/products
Knowledge of AZ Business and processes

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.

The annual base salary for this position ranges from $135,182.40 - 202,773.60 USD Annual

However, 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) or to receive a retirement contribution (hourly 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 salary (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.

Date Posted 12-Nov-2026 Closing Date 11-Nov-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Apply on astrazeneca.eightfold.ai About employer

Report this job

Work requirements

Jobs in the United States