• Regulatory Affairs Group Director, Regulatory Affairs Management... Barcelona
  • AstraZeneca in Barcelona, , Spain
  • jobs
  • 3 weeks ago

jobs description

Job Title: Regulatory Affairs Group Director, Regulatory Affairs Management Vaccines & Immune Therapies

Grade F 

Location: Barcelona, Spain 

Salary: Competitive & Excellent Benefits Package  

Introduction to Role:

Are you a passionate leader with an extensive experience within regulatory affairs and drug development? Do you possess leadership skills? Then, join us in Vaccines & Immune Therapies 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 Barcelona, for a Regulatory Affairs Group Director to join the Vaccines & Immune Therapies 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. We have a culture of continuous learning and knowledge sharing and we aspire to match the... business needs with team members’ individual development aspirations.

What You’ll Do

As a Regulatory Affairs Group Director, you will be responsible for recruitment and line management of up to 10 regulatory professional staff. You will contribute to the strategy, direction and efficient operation of Vaccines & Immune Therapies Regulatory as well as the wider Regulatory Affairs Management (RAM) community. You will also take responsibility for continuous improvement or drug projects.

How will you make a difference?

In this role, you will:
• Provide leadership, coaching and line management for up to 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 stakeholders 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 Vaccines & Immune Therapies 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 expert and/or process area.
• Take on responsibility to drive continuous improvement, change or drug projects.
• 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 discipline
• 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, stakeholder management and negotiating skills.
• Excellent written and verbal communication skills

Desirable for the role
• Knowledge of Vaccine and/or immune therapy 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
Barcelona Spain


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