Regulatory Affairs Specialist (12-months fixed-term contract)

Location: Dublin
Competitive salary & Excellent company benefits
 

Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise to make a difference to the lives of 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

You will deliver and maintain competitive licences for Ireland/Malta commercial brands and ensure regulatory compliance for defined product and project responsibilities, including project leadership.

You will provide GxP support to ensure full compliance with GxP requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards and you will act as Local Recall Administrator for the IE market ensuring products are recalled from the IE market in line with the relevant SOP and regulatory guidance.

Other responsibilities will include:

Regulatory Compliance & Governance

• Ensure timely submission and approvals of all regulatory applications and compliance with Ireland/Malta regulatory requirements
• Ensure adherence to appropriate standards and policies for all aspects of the company’s regulatory activities
• Provide regulatory input to stock and supply issues
• Liaise with Operations to manage pack changes and ensure labelling compliance
• Liaise proactively and participate as a member of cross-functional delivery teams, providing regulatory advice
• Ensure timely submission of DSUR’s when relevant

Generate Competitive Licence

• Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
• Develop professional working relationships with assessors and administrative staff within the regulatory agencies
• Prepare high quality regulatory applications and regulatory responses for Ireland/Malta (including input to responses for European applications)

Commercial Support

• Actively contribute to cross-functional teams working within Medical Affairs and other areas of the business
• Support the delivery of commercial objectives, including representing Regulatory Affairs on appropriate cross-functional teams
• Ensure Abridged Prescribing Information is prepared and maintained in accordance with the licence
• Provide regulatory input relating to commercial brands, including competitor intelligence

Formulate & Influence Regulatory Strategy

• Understand and promote Irish/Maltese business needs into European strategies on drug development and regulatory filings/issues as relevant
• Ensure appropriate cross functional input into the delivery of optimal licence strategies
• Represent the company at IPHA Regulatory Affairs Executive Group

Lead the Organisation & Improve Productivity

• Plan and execute the workload for defined product responsibilities in consultation with the Head of Regulatory Affairs
• Lead the regulatory team meetings, issuing minutes, invitations and reminders.
• Keep up-to-date with developments in the Regulatory environment and share this knowledge across the department and beyond, in the business interest
• In collaboration with the team, drive continuous improvement and best practice through sharing experiences and contributing to establishing best practices
• Ensure optimal departmental processes through continuous review
• Actively contribute to the development, coaching and training of the department, including new starters
• Consistently constructive, contributing, adaptable member of the department.

GXP Compliance Support

• Support in ensuring effective operational implementation of the quality management system across all GxP areas
• Support in maintaining business continuity plans for GxP functions
• Support the GxP Country Quality Lead to ensure self-assessment plans, continuous improvement plans and training plans are completed on time across the GxP functions
• Providing support at the GxP committee meetings as needed, through minute taking and provision of summaries.

Essential for the role

• Life Sciences Degree or appropriate professional qualifications
• 1-2 years’ experience in EU regulatory affairs
• Good written and verbal communication skills
• Excellent attention to detail
• Demonstrable negotiation skills
• Ability to make optimal use of IT systems
• Experience with CESP submissions and eCTD lifecycle maintenance

Desirable for the role

• Post-graduate qualification
• Experience in the pharmaceutical industry with time spent in a commercially aware business role
• Experience with clinical trial applications
• Experience in mentoring less experienced staff

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 5 Sep 2021.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.