Regulatory Affairs Group Director – Respiratory & Immunology

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Build unrivalled capabilities in a place that promotes learning agility and offers development opportunities. We never stand still so you’ll have the chance to constantly grow your abilities, skills and knowledge. Here we are a fusion of challenging and interesting work, in an energising and inspiring environment!

Who we are

A high performing team, we are united and motivated by our shared purpose – to deliver life-changing medicines. We come to work each day to make a difference – to patients, society and our company.

Are you a passionate leader with an extensive experience within regulatory affairs and drug development? Do you possess leadership skills? Then, join us in Late Respiratory & Immunology Regulatory Affairs and provide leadership to a team of internal and contract staff leading regulatory submissions to Regulatory Authorities around the world.

A permanent opportunity has arisen, based in Macclesfield, for a Regulatory Affairs Group Director to join the Late Respiratory & Immunology Regulatory Affairs Management (RAM) Leadership team. You will use your regulatory expertise and oversight to support and develop your team members to ensure high quality and efficient drug project delivery.

What you’ll do

As a Regulatory Affairs Group Director, you will be responsible for recruitment and line management of 10+ regulatory professional staff. You will contribute to the strategy, direction and efficient operation of Late Respiratory & Immunology Regulatory as well as the wider Regulatory Affairs Management (RAM) community.

How will you make a difference?

In this role, you will:

  • Provide leadership, coaching and line management for 10+ direct reports. Ensure the principles of both individual and team performance development are used to develop staff to their full potential.
  • Attract and recruit talent. Be an ambassador for the RAM group, able to engage partners and clearly articulate the RAM roles and responsibilities.
  • As a member of the RAM Leadership Team, proactively contribute to the strategy, direction and efficient operation of the group.
  • Assignment of RAM resources to meet the drug project and improvement project needs in collaboration with the wider Regulatory Respiratory & Immunology leadership team and Lead Regulatory Project Managers, ensuring cost effective and flexible resource management which is aligned with Therapy Area (TA) priorities.
  • Contribute to management of the budget and head count, identifying budget priorities taking careful note of global portfolio changes and business needs.
  • Ensure own work and work of direct reports adheres to and remains in compliance with AZ standards, processes, AZ group policies and corporate responsibilities.
  • Use regulatory knowledge to support individuals with activities at a global and/or regional level to ensure delivery of project objectives on time and to appropriate quality.
  • Drive a culture of continuous improvement, learning and knowledge sharing
  • Lead development and continuous improvement of specialist and/or process area. Take on responsibility as subject matter expert to drive continuous improvement or change project.
  • Collaborate with the wider global regulatory organisation to drive the development of leading edge RAM capabilities as well as system and process improvement driving productivity gains

Essential for the role

  • Bachelor’s Degree in Science or a related subject area
  • Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
  • Knowledge of regulatory procedures and legislation for drug development, throughout the product lifecycle
  • Proven successful leadership and project management experience
  • Proven ability to develop others to meet personal aspirations and business needs
  • Proven ability to drive and implement change and improvement projects
  • Strong influencing, partner management and negotiating skills.
  • Excellent written and verbal communication skills

Desirable for the role

  • Knowledge of Respiratory and/or immunology aspects of regulatory
  • Managed first wave Marketing Application and/or Life Cycle Maintenance submissions.
  • Managed complex regulatory deliverables across projects/products.
  • Facilitation skills
  • Knowledge of AZ business and processes.

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on 9th August 2021 and we welcome with your application; CV and cover letter, no later than 23rd August 2021

For more information please contact: alexander.doyle@astrazeneca.com

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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