Regulatory Affairs Manager (V&I)

Regulatory Affairs Manager - Vaccines & Infections

London, UK

Competitive salary, bonus & benefits

​Closing Date: 30th June 2023

Do you have expertise in Regulatory Affairs and passion for improving patient lives? Would you like to apply your expertise to impact the service 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 BioPharmaceutical business 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.

There are countless opportunities to develop and grow with AstraZeneca – working with top people to build a diverse career and learn what Commercial looks like at its best. A crucial step on the journey to being a future leader – it’s a fantastic opportunity if you’re up for the challenge.

At AstraZeneca UK, we bring life-changing medicines to patients across England, Scotland, Wales and Northern Ireland. As a member of the Association of the British Pharmaceutical Industry (ABPI), all of our sales, marketing and communications activities are subject to the ABPI Code of Practice. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us!

What you’ll do

• Identify regulatory strategies to support commercial and business objectives and company efficiencies. Plan and complete workload for the defined product responsibilities and agreeing plan with Regulatory Affairs Lead
• Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
• Prepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications)
• Provide regulatory input to commercial, medical affairs, market access, medical information, patient safety and supply chain functions.
• Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK regulatory requirements
• Assure appropriate standards and policies for all technical aspects of the company’s activities in Regulatory Affairs are adhered to
• Provide regulatory input/solutions to supply and stock issues
• Liaise with Operations to manage pack changes and ensure labelling compliance
• Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence
• Provide strategic regulatory input relating to AZ promoted and cornerstone brands, including competitor intelligence
• Project manage and deliver projects of commercial strategic value
• Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues
• Ensure appropriate cross functional input into the delivery of optimal licence strategies
• Keep up-to-date with developments in the Regulatory environment and share this knowledge across the department and beyond, in the business interest
• Ensure optimal departmental processes through continuous review
• Actively give to the development, coaching and training of the department, including new starters
• Proactively manage the regulatory process for clinical trials for UK

Required qualifications & experience

• Life Sciences Degree or appropriate professional qualifications
• Significant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company
• Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role

Desired qualifications & experience

• Therapy Area Expertise in one of the following diseases or technology areas: Respiratory, immunology, vaccines, infections, injectable biologics, inhaled medicines or medical devices
• Experience in creating and delivering regulatory strategies
• Postgraduate qualification

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?

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

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If you have site, country or departmental social media then feel free to switch any of the above links.

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.