Regulatory Affairs Manager

AstraZeneca•Gaithersburg, MD

3d•$109,245 - $163,867•Hybrid

About The Position

Are you ready to lead regulatory submissions that accelerate access to life-changing medicines? Do you thrive in a dynamic setting where your judgment shapes approval pathways and your work directly impacts patients in need? As a Regulatory Affairs Manager, you will own end-to-end planning, coordination and delivery of regulatory submissions across regions and modalities, translating scientific strategy into high-quality applications that secure timely approvals. You will identify risks and opportunities, advise cross-functional teams on procedural and documentation requirements, and guide products through development, authorization and lifecycle management. This role places you at the heart of a science-led organization focused on getting the right medicines to the right patients, faster than ever before. You will work with diverse teams, influence submission strategy, and help set the standard for how we partner with Health Authorities to achieve rapid, global approvals.

Requirements

Bachelor’s degree in science or a related field with 3+ years of regulatory experience within the biopharmaceutical industry or 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 and facilitate scientific discussions
Proficiency with common project management (e.g., MS Project) 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

Nice To Haves

Regulatory experience
Managed regulatory deliverables at the project level
Thorough knowledge of the drug development process
Knowledge of AZ Business and processes

Responsibilities

Understand the regulatory framework and regional trends for small and large molecules across all regions, informing submission strategy and procedural choices to maximize speed and quality of approvals.
Lead and contribute to planning, preparation (including authoring where relevant) and delivery of simple and, with experience, increasingly complex submissions throughout the product lifecycle from global and/or regional perspectives; connect immediate deliverables to future label and lifecycle opportunities.
Provide regulatory input on Health Authority requirements for assigned deliverables, including submission delivery strategy per market/region, review of documents (e.g., response documents, study protocols, PSRs), and analysis of regulatory procedures and special designations used during development, authorization and extension.
Use and share best practices when handling various applications and procedures during interactions with Health Authorities and in day-to-day work, operating effectively in a highly dynamic environment to drive confident, consistent outcomes.
Develop, execute and maintain submission delivery plans and content plans; proactively provide status updates to stakeholders; coordinate input, maintenance and revisions in Planit project plans; highlight unforeseen changes in demand to the Lead RPM and line manager.
Identify regulatory risks early and propose clear mitigations to the Lead RPM and cross-functional teams, protecting timelines and the quality of submissions.
Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF and document management, collaborating with GRO, Markets, CROs and alliance partners where relevant.
Provide regulatory expertise and guidance to cross-functional teams, working flexibly across regions to ensure business objectives are met and strategic value is realized.
Provide coaching, mentoring and knowledge sharing within the RAM skill group, building capability and raising the bar on quality and consistency.
Contribute to process improvement, applying lessons learned to make future submissions faster, clearer and more impactful.