Regulatory Affairs Therapy Area Lead – Respiratory and Immunology (R&I)
Competitive salary and benefits
Closing date: 9th June 2021
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
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. With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.
We are looking for passionate colleagues to join our team as a Regulatory Affairs Therapy Area Lead.
In combination with your regulatory expertise, successful candidates will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
It is important that you embrace novel regulatory tools and technology so that the medicines we develop will benefit from latest approaches in regulatory science.
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.
Role duties and responsibilities:
Manage regulatory processes for products within defined Therapy Area.
Deliver and maintain competitive licences for UK including driving regulatory strategy for new initiatives. Ensuring regulatory compliance for defined product and project responsibilities, including project leadership and line management.
Timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for 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 working within a Regulatory Affairs organisation in a UK-based on Global Pharmaceutical company
Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
- Demonstrable negotiation skills
Therapy Area Expertise in one of the following diseases or technology areas: Respiratory, Oncology, injectable biologics, inhaled medicines, medical devices
Experience in creating and delivering regulatory strategies for Orphan drugs applications and/or paediatric indications.
- Strong working knowledge of MHRA requirements immediately post-Brexit
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.
Where can I find out more?
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