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Regulatory Affairs Therapy Area Lead - Respiratory and Immunology (R&I) & Vaccines and Immune T[...]

TN United Kingdom

London

Hybrid

GBP 60,000 - 100,000

Full time

Yesterday
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Job summary

An established industry player is seeking a Regulatory Affairs Therapy Area Lead to spearhead regulatory strategies in the Respiratory and Immunology sectors. This role involves ensuring compliance, managing clinical trial approvals, and leading teams to uphold high regulatory standards. The company promotes a collaborative environment, typically requiring in-person attendance three days a week while offering flexibility. Join this innovative firm to make a significant impact on patients' lives and advance your career in a thriving life sciences hub.

Qualifications

  • Extensive experience in Regulatory Affairs within a UK or global pharmaceutical setting.
  • Strong knowledge of MHRA requirements and operational regulatory experience.

Responsibilities

  • Develop and oversee regulatory strategies for products in specific Therapy Areas.
  • Ensure compliance and lead projects while managing teams.

Skills

Regulatory Affairs
Compliance
Project Management
Clinical Trial Approvals
MHRA Requirements
Knowledge of Respiratory and Immunology

Education

Life Sciences Degree
Relevant Professional Qualifications

Job description

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

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Client:
Location:

London, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

c0ad30d0390a

Job Views:

8

Posted:

26.04.2025

Expiry Date:

10.06.2025

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Job Description:

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

London

Competitive Salary & Benefits

Introduction to role:

We are seeking a Regulatory Affairs Therapy Lead to develop and oversee regulatory strategies for products within specific Therapy Areas. Responsibilities include obtaining and maintaining licenses in the UK, guiding regulatory strategies for new projects, ensuring compliance, leading projects, and managing teams. You will also handle clinical trial approvals and uphold high regulatory standards locally.

Additionally, you will support the development of AZ investigational and licensed products through contributions to MC3 projects, feasibility studies, scientific advice, and other activities, ensuring compliance with GRP and AZ policies.

  • Life Sciences Degree or relevant professional qualifications
  • Extensive experience in Regulatory Affairs within a UK or global pharmaceutical setting
  • Operational regulatory experience with a focus on commercial roles
  • Strong knowledge of MHRA requirements
  • Expertise in one of the following areas: Respiratory, Cardiovascular, Diabetes, Renal, Oncology, biologics, inhaled medicines, medical devices, vaccines
  • Experience with orphan drugs and pediatric indications regulatory strategies

We promote in-person collaboration, typically three days a week, balanced with flexibility. Join us to make a meaningful impact and grow professionally.

Why AstraZeneca?

At AstraZeneca, we lead in medical innovation and foster relationships with experts, policy makers, and patient groups. We seek resilient, communicative, and innovative individuals ready to bring new ideas to life.

Our UK missions include:

  • Positioning the UK as a global life sciences hub
  • Providing fast, equitable access to medicines and high-quality care
  • Leading sustainably for health, society, and the planet

Our Pancras Square headquarters connects us to our ecosystem and enhances collaboration.

Ready to impact patients’ lives and your career? Apply now!

Date Posted

18-Jun-2024

Application Deadline

30-Jun-2024

We are committed to diversity and inclusion, welcoming applications from all qualified candidates and providing accommodations as needed.

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