International Regulatory Affairs Manager

2 weeks ago

Subang Jaya, Selangor, Malaysia AstraZeneca Full time

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 Manager to join our International Regulatory Affairs Management (RAM) team.

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

The Regulatory Affairs Manager in International Regulatory Affairs will be responsible for tactical delivery of International submission 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 Manager 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.
  • Leads and/or contributes to the planning, preparation (including authoring where relevant) and delivery of complex regulatory maintenance submissions from an International market perspective
  • Liaises closely with crossfunctional team 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 planning tools for assigned projects and highlights 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.

  • Provides coaching, mentoring and knowledge sharing within the International regulatory organisation.
  • Actively seeks Continuous Improvement opportunities.

Minimum Requirements -Education and Experience

  • Relevant University Degree in Science or related discipline
  • Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry, focusing on International markets including new MAAs, licence maintenance and labelling
  • General knowledge of drug development
  • Strong project management skills
  • Good knowledge of the Regulatory new MAA rollout and product maintenance process
  • Knowledge of International markets in some or all Int'l regions
  • Leadership skills, including experience leading multidisciplinary project teams

Preferred Experience

  • Regulatory affairs experience across a broad range of International markets
  • Experience in Veeva Regulatory Information Management system (RIM)
  • Managed regulatory deliverables at the project level
  • Experience of working with people from locations outside of Malaysia 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

WHY JOIN US?
We believe there's always a better way of doing things.

Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.

Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout

SO, WHAT'S NEXT?

WHERE CAN I FIND OUT MORE?
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national

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