Senior Director CMC Technical Authoring – Global Technical Operations

Do you want to play a pivotal role in channeling our scientific capabilities and make a positive impact on changing the lives of patients? Join us as our Senior Director CMC Thechnical Authoring in Global Technical Operations!

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.

Global Biologic Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations and biopharmaceutical manufacturing.

Your opportunity to make a difference

We can now offer an exciting opportunity to join Global Technical Operations (GTO) as our Senior Director CMC Technical Authoring. The role is based at our manufacturing site in Södertälje, Sweden. You will report to Vice President, Global Technical Operations

What you will do

As Senior Director CMC Technical Authoring, you will hold a strategic leadership role covering Biologics commercial products. Working closely with Biopharmaceutical Development, Pharmaceutical Technology & Development, Manufacturing, Supply, Quality and CMC Regulatory Affairs, you will provide regulatory leadership across GTO and our partners. Alongside regulatory strategy and lifecycle management, you will be accountable for enabling our future-state digital regulatory capability, including AI-enabled authoring, structured content management, regulatory knowledge management and automated post-approval submission processes. Your primary responsibility will be to lead the authoring of post-approval regulatory submissions for Biologics.

Digital & AI Submissions Transformation

You will help shape and drive the future of AI-enabled regulatory operations, leading the transformation of post-approval submissions through generative AI, automation and structured content management. In close partnership with Digital, Data & AI, IT, Quality and Regulatory Affairs, you will drive the development of connected regulatory knowledge, intelligent authoring solutions and reusable content that improve speed, consistency and quality across the submission lifecycle.

You will also establish robust governance and GxP-compliant approaches for AI-enabled solutions, define measures of impact and adoption, and lead the organisational change and capability building required to embed new ways of working. With a strong external perspective, you will help position GTO at the forefront of AI-enabled regulatory strategy and advance the long-term ambition of increasingly autonomous preparation of routine post-approval submissions.

Key Responsibilities

• Create and execute a 3–5 year roadmap enabling independent authoring of post-approval submissions using AI, automation, and structured content management.
• Implement generative AI solutions for drafting, summarization, impact assessments, comparability narratives, health authority responses, and lifecycle management documentation.
• Partner with Digital, Data & AI, IT, Quality, and Regulatory Affairs organizations to deploy regulatory copilots and document intelligence solutions.
• Lead organizational change management, training, and capability-building for digital and AI-enabled regulatory operations.
• Benchmark external industry practices and position GTO as a leader in AI-enabled regulatory strategy and lifecycle management.

Essential Requirements

• Bachelor’s or Master’s Degree in Life Science or related discipline
• Extensive experience in regulatory affairs, including leading regulatory or cross-functional teams and direct interaction with health authorities
• Proven expertise in navigating international regulatory environments and driving regulatory strategy, project delivery, and compliance for pharmaceutical products
• Demonstrated leadership, strategic thinking, and the ability to evaluate risks and business impacts in ambiguous, complex settings
• Highly developed written, verbal, and interpersonal communication skills with experience influencing key decisions and building effective partnerships
• Strong program management skills and experience in resource planning and operational oversight

Desirable Experience/Knowledge

• Advanced degree (PhD, PharmD) or further professional qualifications
• Experience across multiple therapeutic areas or within regulatory operations, drug project delivery, or compliance in a global context
• Knowledge of evolving global and regional regulations and best practices

Are you already imagining yourself in this role? Good, because we can´t wait to hear from you!

Why AstraZeneca

At AstraZeneca, you will be part of a community united by one purpose: delivering medicines to patients quickly, reliably and sustainably. Your experience and leadership will be valued as you bring people, processes and partners together to strengthen our global supply network. Here, you will have the space to share your ideas, grow alongside skilled colleagues and make an impact that reaches far beyond your immediate team.

What’s next

If this sounds like the kind of challenge where you could bring your strengths and continue to grow, we would love to hear from you. Join us in leading a dedicated team, shaping the future, and helping medicines reach the patients who need them.

We look forward to getting to know you. Please submit your application by no later than November 17, 2026.

Date Posted

Closing Date