Regulatory Affairs Specialist- Oncology

Job Description

Regulatory Affairs Specialist

London

Competitive Salary and Benefits

Closing Date: 16th August 2021

Do you have experience within the pharmaceutical industry preferably with exposure within Regulatory Affairs and have spent time in a commercially aware business role? If yes, we would love to hear from 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.

Here we accelerate change through building partnerships. It’s by furthering relationships externally that we can do something truly important. We are always broadening our relationships with leaders with vision to include policy makers.

If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us!

It has been agreed that our AstraZeneca UK Commercial head office will move from Luton to Pancras Square, London in early 2022. This role will be initially based in our Luton office, until this move takes place.

Our move to Pancras Square, London offers us the strongest possible platform to transform the lives of patients in the UK, as the country’s leading biopharmaceutical company. It will bring AstraZeneca UK closer to our customers and partners in the UK’s healthcare environment, as well as develop greater collaboration with the wider AstraZeneca footprint.

What you’ll do

• Deliver and maintain competitive licences for UK commercial brands. Ensuring regulatory compliance for defined product and project responsibilities, including project leadership.
• Timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for UK achieved through provision of local regulatory expertise.
• Ensure timely submission and approvals of all licensing applications and compliance with UK regulatory requirements
• Assure appropriate standards and policies are maintained for all technical aspects of the company’s regulatory activities are adhered to
• Provide regulatory input to stock and supply issues
• Liaise with Operations to manage pack changes and ensure labelling compliance
• 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 UK (including input to responses for European applications)
• Actively contribute to cross-functional team working within the Medical & Regulatory Department and other areas of the business
• Support the delivery of commercial objectives, including representing Regulatory Affairs on appropriate cross-functional teams
• Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues
• Proactively manage the regulatory process for clinical trials for UK

Essential for the role

• Experience in or awareness of the pharmaceutical industry Demonstrable negotiation skills
• Ability to make optimal use of IT systems
• Life Sciences Degree or appropriate professional qualifications

Desirable for the role

• Experience in the pharmaceutical industry with time spent in a commercially aware business role
• Post-graduate qualification

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a phenomenal Place to Work. Where you are empowered to push the boundaries of science and fuel your ambitious spirit. There’s no better place to make a difference to medicine, patients and society. A broad culture that fosters diversity and teamwork, 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 already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en