AstraZeneca Hiring Regulatory Affair Manager

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that concentrates on the discovery, development and commercialization of prescription medicines addressing some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Post : Regulatory Affairs Manager II

Job Description
The Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned global deliverables in the maintenance Center of Excellence, as an individual contributor. The Regulatory Affairs Manager II may have to take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their Portfolio director.
The Regulatory Affairs Manager II is fully proficient in applying established standards to perform regulatory affairs management for moderately complex products/regions and under minimal supervision. Capable of leading cross functional activities. Participates in continuous improvement of process and tools/systems

Accountabilities / Responsibilities :
Regulatory Affairs Management
• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
o Submission delivery strategy of all dossiers including established brands and all application types per market and /or region including Divestments, Marketing authorization transfer (MAT) and withdrawals.
o Provide scientific contribution to single documents such as PSRs, response documents, , regulatory maintenance documents Risk Management Plans, , Addendum to Clinical and NonClinical Overview, Pharmacovigilance agreement (PVA), Core labelling documentation (e.g. Company Core Data Sheets, USPI, EUQRD and Core Safety Profiles), etc.
o Analysis of regulatory procedures and special designations used during development, authorization and extension of the product.
• Uses and shares 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.
• Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions
• Liaise closely with cross-functional members with aligned product responsibilities.
• Develops, executes and maintains submission delivery plans, submission content plans using digital tools like Veeva Vault (ERV) and compliance, and proactively provides status updates to designated stakeholders.
• Coordinates the input, maintenance and revision in the project planning tools for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identifies regulatory risks and proposes mitigations to Lead RPM and cross functional teams.
• Supports operational and compliance activities for assigned results, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.
• Provides coaching, mentoring and knowledge sharing within the regulatory organization.
• Contributes to process improvement.
• Use available AI tools effectively and responsibly to improve efficiency, streamline routine activities, and support high-quality regulatory deliverables

Candidate Profile
• Relevant University Degree in Science or related discipline
• Minimum 8+ years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets General knowledge of drug development
• Thorough knowledge of the regulatory product maintenance process
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams.
• The US Regulatory affairs experience
• Managed regulatory deliverables at the project level
• Experience of working with people from locations outside of India, especially Europe and/or USA

Skills and Capabilities
• Excellent English 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
• Basic understanding of emerging technologies like AI, ML etc
• Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration and learning
• Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making.
• 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

Additional Information
Experience : 8+ years
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affair
End Date : 31-Oct-2026