Astrazeneca
Biopharmaceutical
InternationalAssociateRegulatoryAffairsDirectorI
Neural analysis suggests this role is
optimal for Director candidates.
“International Associate Regulatory Affairs Director I at Astrazeneca. Skills: Regulatory Affairs, International Markets, MAA submissions. Provide expert regulatory advice. Provide project management”
What You'll Achieve.
Accelerate approvals; Bring life-changing medicines to patients faster; Speed up filings; Ensure right-first-time submissions
Industry & Context.
Analyze problems; Recommend actions; Risk identification; Mitigation planning
Relocation required
What They're Looking For.
Must Have
Relevant University Degree in Science, 10+ years extensive regulatory experience, Biopharmaceutical industry experience, Experience with International markets, Experience with new MAAs, Experience with CLE’s, Experience with licence maintenance, Experience with labelling, Thorough understanding of drug development, Thorough understanding of International market Regulatory Frameworks, Thorough knowledge of regulatory submission processes, Project management skills, Stakeholder management skills, Highly developed interpersonal skills, Leadership skills, Experience leading multi-disciplinary project teams, Working with Global functions, Working with time zones, Expert knowledge of International markets, Proven track record of management, Detailed regulatory requirements for International market MAA’s, Detailed regulatory requirements for CLE’s, Detailed regulatory requirements for LCM activities, Excellent English written communication skills, Excellent English verbal communication skills, Cultural awareness, Scientific knowledge, Proficiency with MS Project, Proficiency with Office Timeline Pro, Proficiency with Veeva Systems, Ability to work independently, Ability to work as part of a team, Influencing skills, Collaborator management skills, Ability to analyze problems, Ability to recommend actions, Continuous Improvement focused, Knowledge sharing focused
Nice to Have
Great understanding of Global Regulatory processes, Great understanding of Global Regulatory tools, In depth International markets experience, Managed complex regulatory deliverables, Experience working with people from India, Experience working with people from International regions, Understanding of major global Health Authority procedures
What You'll Do.
Provide expert regulatory advice
Provide project management
Manage end-to-end Marketing Authorisation Applications
Manage Clinical Line Extensions
Manage Life Cycle Management
Apply expertise in International regulatory affairs
Improve submission delivery strategies
Lead tactical delivery of dossiers
Coordinate LCM applications
Coordinate review of Health Authority Questions
Coordinate responses to Health Authority Questions
Build shared international submission
Implement shared international submission
Align objectives with International Regulatory teams
Remove obstacles to rapid filings
Build positive relationships with marketing companies
Build positive relationships with cross-functional partners
Maintain positive relationships with marketing companies
Maintain positive relationships with cross-functional partners
Leverage positive relationships with marketing companies
Leverage positive relationships with cross-functional partners
Lead planning of maintenance submissions
Contribute to planning of maintenance submissions
Lead authoring of maintenance submissions
Contribute to authoring of maintenance submissions
Lead delivery of maintenance submissions
Contribute to delivery of maintenance submissions
Ensure operational rigor in document management
Ensure operational rigor in compliance
Act as subject matter expert
Understand evolving regulatory frameworks
Apply learnings from international submissions
Enable knowledge sharing
Maintain up to date regulatory knowledge
Apply best practices when interacting with health authorities
Develop submission delivery plans
Maintain submission delivery plans
Develop content plans
Maintain content plans
Provide proactive status updates
Coordinate inputs in project planning
Coordinate updates in project planning
Anticipate resource needs
Articulate resource needs
Identify regulatory risks early
Lead mitigation planning
Model effective delivery
Seek continuous improvement
Implement continuous improvement
How You'll Work.
Team & Collaboration
Global and regional regulatory leaders; Marketing companies; Global operations; Labeling; Manufacturing; Patient safety; Development teams; International Regulatory teams; Cross-functional partners; Multi-disciplinary project teams
Communication Scope
English written communication; English verbal communication
Process & Methodology
Project planning, Submission delivery plans, Content plans, Risk mitigation planning
Full Job Description
**Job Title: International Associate Regulatory Affairs Director I** **Global Career Level: E1** **Role Type: Individual Contributor for International Markets** **About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. **About the role** **Introduction to role:** Are you ready to accelerate approvals across diverse international markets and bring life-changing medicines to patients faster? This permanent role, based in India, sits at the heart of our efforts to move complex, innovative products through registration with speed and precision—so no patient waits As International Associate Regulatory Affairs Director I, you will provide expert regulatory advice and project management within a high-performing team focused on tactical excellence and rapid delivery. You will work across our oncology portfolio partnering closely with global and regional regulatory leaders. You will manage end-to-end Marketing Authorisation Applications, Clinical Line Extensions and Life Cycle Management. Can you see yourself turning insight into action, removing barriers, and ensuring right‑first‑time submissions that translate science into approved medicines? **Accountabilities:** Apply expertise in International regulatory affairs to improve submission delivery strategies for assigned products and markets whilst leading the tactical delivery of dossiers for new MAAs, CLEs, and LCM applications and coordinating, review, and responses to Health Authority Questions. Build and implement shared international submission to speed up filings. Collaborate with directors and International Regulatory teams passionate about international regulatory affairs to align objectives an
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