Regulatory Affairs Therapy Area Lead - Respiratory and Immunology (R&I) & Vaccines and Immune Therapies (V&I)

Regulatory Affairs Therapy Area Lead - Respiratory and Immunology & Vaccines and Immune Therapies

London

Competitive Salary & Benefits

Advert Closing Date: 30th June 2024

Introduction to role:

We are looking for a Regulatory Affairs Therapy Lead to drive strategy and regulatory processes for products within the defined Therapy Areas. This role involves delivering and maintaining competitive licenses for the UK, driving regulatory strategy for new initiatives, and ensuring regulatory compliance for defined product and project responsibilities. This includes project leadership and line management. You will also be responsible for the timely delivery of clinical trial approvals and maintaining high regulatory compliance standards for the UK through the provision of local regulatory expertise.

You will also 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 ensuring full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards including GRP Lead role where applicable.

Essential Skills/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

Demonstrable negotiation skills

Strong working knowledge of MHRA requirements

Desirable Skills/Experience:

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, vaccines

Experience in creating and delivering regulatory strategies for Orphan drugs applications and/or paediatric indications

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

At AstraZeneca's Biopharmaceuticals Business Unit, we are at the forefront of medical leadership across our enterprise and the healthcare ecosystem. We shape the future of Healthcare by nurturing relationships with external experts to do something truly meaningful. We are always broadening our relationships with thought leaders to include policy makers and patient groups. This is a place for strong communicators, resilient and fast-paced individuals who bring new ideas to the table then make them a reality.

At AstraZeneca UK, we are committed to delivering against three missions:

Accelerating the position of the UK as a global centre of excellence in life sciences

Redefining healthcare through fast and equitable access to the most effective medicines, high quality care

Delivering sustainable leadership that prioritises healthy people, society and planet

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

Are you ready to make a meaningful impact on patients' lives and your personal growth?

There's never been a better time to join our thriving BioPharmaceuticals team. Apply now!

Date Posted

18-Jun-2024

Closing Date

30-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.