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Regulatory Affairs & Patient Safety Administrator


Regulatory Affairs & Patient Safety Administrator (fixed-term contract)

Location: Dublin
Competitive salary & Excellent company benefits

Do you have expertise in, and passion for, Regulatory Affairs, Medical Information & Patient Safety? Would you like to apply your expertise to make a difference to the patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

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

Business Area

It’s our patients that come first, every decision we make and action we take is centred around how we can better serve them. It’s why we are shaping patient care for the future, working along the whole experience to give hope to billions of lives across the world.

What you’ll do

In this role you will be working in close collaboration with the IE Regulatory Team to ensure full regulatory compliance for defined product and project responsibilities and compliance with requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards. You will also work closely with the Medical Information & Patient Safety (MIPS) team to provide Medical Information to external customers, reporting Adverse Events and Product Quality Complaints in line with Company SOPs.

Other responsibilities will include:

Regulatory Affairs

  • Ensure timely submission and approvals of all licensing applications and compliance with Ireland/Malta regulatory requirements
  • Prepare and submit, according to agreed timelines, high quality post-licencing regulatory applications, including variations, and Article 61(3)s in order to maintain and update existing marketing authorisations, under supervision
  • Assist with archiving of regulatory documentation
  • Working in close collaboration with the IE Regulatory Affairs team and Supply and Operations to manage pack changes and ensure labelling compliance
  • Drafting product Abridged Prescribing Information and ensuring this is in accordance with the licence
  • Communicate significant regulatory issues/developments to medical and commercial functions including the potential impact on the AstraZeneca Ireland business.
  • Ensure AZ Global functions are kept informed of status of submissions and liaise with AZ Global on regulatory issues as relevant.
  • Complete independent checks of regulatory product information including artwork review and approval
  • Assist with maintenance and update of internal databases

Compliance Support

  • Assist with the development and maintenance Standard Operating Procedures (SOP’s) and guidelines as required
  • Provision of support during any inspections and/or audits
  • Maintain awareness of external legislation and guidelines
  • Ensure compliance with external legislation and internal AZ requirements and Quality Management System
  • Support the Head of Regulatory Affairs with GxP administrative tasks to ensure compliance, identifying, highlighting and resolving issues if required
  • Build relationships with the HPRA, Irish Pharmaceutical Healthcare Association (IPHA) and colleagues both internally and externally

Medical Information & Patient Safety Support

  • Assist colleagues in covering annual leave or other business absences
  • Working in close collaboration with the Patient Safety Specialist and Lead on the provision of Medical Information to external customers and to AZ marketing and Sales Force in a timely manner
  • Reporting Adverse Events and other Safety-related reports in accordance with AZ SOPs
  • Reporting of Product Quality Complaints in line with AZ SOPs
  • All activities will be conducted in an ethical, responsible and lawful manner as set out in the AZ Global Policies & Standards and complying with the Irish Pharma Code and Legislation

Essential for the role

  • Life Sciences Degree or appropriate professional qualifications
  • Some experience in the pharmaceutical industry
  • Ability to make optimal use of IT systems
  • Proactive and flexible self-starter
  • Consistently constructive, contributing, adaptable member of the department.
  • Excellent attention to detail

Desirable for the role

  • Experience in a regulatory affairs, patient safety or medical information role.
  • Knowledge of pharmacovigilance requirements in EU/Ireland.
  • Knowledge of regulatory requirements for medicines in EU/Ireland.

Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Interested? Apply now by submitting your CV no later than 31st May 2021

Where can I find out more?

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