Regulatory Affairs Senior Specialist

hace 7 días

La Paz, Baja California Sur, México AstraZeneca A tiempo completo

Regulatory Affairs Senior Specialist


Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets.

We work across the AZ pipeline and business to accelerate Regulatory approvals for new medicines in International markets as efficiently and effectively as possible so that no patient waits.


A fantastic permanent opportunity has now arisen for a Regulatory Affairs Senior Specialist to join our International Regulatory Affairs Management (RAM) team.

The Regulatory Affairs Senior Specialist is a regulatory specialist with project management capabilities responsible for supporting the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor.

The Regulatory Affairs Senior Specialist in International Regulatory Affairs will be responsible for tactical delivery of Intenational submissions including Marketing Authorisation Applications (MAAs), Clinical Line extensions (CLEs) and Life Cycle Maintenance (LCM) within an assigned Global Regulatory Execution Team (GRET) The Regulatory Affairs Senior Specialist is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the International Regulatory Affairs Manager Lead (iRAM Lead) for their allocated projects.


Regulatory Affairs Management

Accountabilities/Responsibilities:

Regulatory Affairs Management

  • Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
  • Coordination, review and authoring contribution to HAQ responses and other associated regulatory maintenance documents
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • Contributes to the planning, preparation (including authoring where relevant) and delivery of simple regulatory maintenance submissions from an International market perspective
  • Liaises closely with crossfunctional members with aligned product responsibilities.
  • Develops, executes and maintains submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Coordinates the input, maintenance and revision in the project plannning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to iRAM Lead and Line Manager.
  • Identifies regulatory risks and propose mitigations to iRAM Lead and cross functional teams.
  • Supports operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management.
  • Contributes to process improvement.

Minimum Requirements -Education and Experience

  • Relevant University Degree in Science or related discipline
  • Minimum 4 years of relevant Regulatory experience within the biopharmaceutical industry, focusing on International markets including new MAAs, license maintenance and labelling
  • General knowledge of drug development
  • Good knowledge of the regulatory New MAA rollout and product maintenance process
  • Strong project management skills
  • Knowledge of International markets in some or all International regions

Preferred Experience

  • Regulatory affairs experience across a broad range of International markets
  • Experience in Veeva Regulatory Information Management system (RIM)
  • Experience of working with people from locations outside of India, especially in the International regions,

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
  • 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

Internal and External Contacts/Customers

  • Global Regulatory Leads (GRLs)
  • Regulatory Regional Leads (e.g., US, EU, International RADs)
  • Lead RPM
  • Other R&D skill groups, eg, Global Regulatory Operations, Global Labelling Group, Operations Regulatory, Patient Safety
  • Operations/Manufacturing organisation (CMC post approval)
  • Marketing Companies/Local affiliates
  • Health Authorities
  • External collaboration partners

Reporting Relationship

  • Direct Reports
  • None
  • Indirect Reports None

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