Regulatory Affairs Therapy Area Lead - Respiratory and Immunology (R&I)

Job Description

Regulatory Affairs Therapy Area Lead - Respiratory and Immunology (R&I)

Location: London

Competitive salary and benefits

Closing date: 23rd August 2021

Do you have expertise in, and passion for, Regulatory Affairs?

We are looking for a strategic and innovative leader to join our team as a Regulatory Affairs Therapy Area Lead.

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!

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 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, partners and stakeholders in the UK’s healthcare environment, as well as foster greater collaboration with the wider AstraZeneca footprint.

Business Area

AstraZeneca’s pipeline of innovative medicines is consistently growing within Respiratory and Immunology (R&I). To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of strategically focused Regulatory Affairs professionals.

Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development

Drive the right approvals for AstraZeneca to realise our ever expanding pipeline. We constructively challenge, pushing each other to think of the best approach and influence external Regulators.

Embrace the variety of challenges here as you work on projects across the entire development process on a wide range of stages and molecules. With absolute accountability for Regulatory strategy and its execution, we are a valued part of the business.

The place to push beyond the traditional ‘Regulatory’ mindset – innovation is at our heart. We think broadly about patients and what it takes to prevent and treat diseases. Powering us to both manage balanced risks as well as spot opportunities.

What you’ll do

As Regulatory Affairs Therapy Area Lead you will:

• Manage Regulatory processes for products within the defined Therapy Area.
• Deliver and maintain competitive licences for the UK driving regulatory strategy for new initiatives.
• Ensuring regulatory compliance for defined product and project responsibilities, including project leadership and line management.
• Ensure timely deliver of clinical trials approvals and maintenance of high regulatory compliance standards for the UK achieved through provision of local regulatory expertise.
• Support the development of AZ investigational and in-licensed/ co-development products through valued contributions to MC3 projects, study feasibility questionnaires, scientific advice meetings and other related activities.
• Full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards.

Essential skills and experience:

• Life Sciences Degree or appropriate professional qualifications
• Extensive 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
• Demonstrable negotiation skills

Desirable:

• Post-graduate qualification
• Therapy Area Expertise in one of the following diseases or technology areas: Respiratory, Cardiovascular, Diabetes, Renal, Oncology, injectable biologics, inhaled medicines, medical devices
• Strong working knowledge of MHRA requirements immediately post-Brexit
• Experience in creating and delivering regulatory strategies for Orphan drugs applications and/or paediatric indications.

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?

If you are inspired by the possibilities of science to make a difference and ready to discover what you can do by joining us on this exciting journey and believe you can contribute to this bold ambition – join us!

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