Associate Director Regulatory Affairs - COE Submission Delivery Team Lead

Position: Associate Regulatory Affairs Director - Centre of Excellence (CoE) Submission Delivery Team Lead (SDTL)
Location: Cambridge, UK
Competitive Salary & Excellent Company Benefits

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are a dynamic, possibility-focused professional, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. We are looking for a forward-thinking and inspiring regulatory project manager to join our team and drive transformational change in our regulatory submissions.

What the Role Involves

The Associate Regulatory Affairs Director - Centre of Excellence (CoE) Submission Delivery Team Lead (SDTL) is an experienced regulatory specialist with strong project management abilities, responsible for leading Marketing Authorisation Application (MAA) and Clinical Line Extension (CLE) cross-functional submission teams to deliver global submissions to support a very healthy oncology portfolio. This role sits in the CoE SDTL SME team within the SDTL pillar of the CoE. This team focuses on SDTL role execution, strategic resourcing, building capability within Oncology Therapeutic Area Disease Units (DUs) and explores efficiency possibilities, requiring a broad scope of skills, regulatory submission-related experience and creative thinking to develop innovative solutions to regulatory challenges.

In this CoE SDTL SME role you will be:

• Partnering with the Global Regulatory Lead (GRL) you will be leading cross-functional delivery teams and sub-teams for the planning, preparation and delivery of complex MAA and/or CLE submissions using and sharing submission delivery plans and best practices. This role requires an inspiring leader who can drive change and motivate teams to achieve exceptional results.
• Identifying regulatory risks and communicate mitigations to stakeholders and cross-functional teams.
• Providing coaching on general SDTL role execution to upskill DU RAMs and ensure role competency. Partnering with new SDTLs and fostering a dynamic learning environment whilst also encouraging original ideas and continuous improvement.
• Acting as the nominated point of contact for DU leaders, with a focus on submission forecasting and SDTL skill gaps. This role requires a possibility-focused professional who can identify opportunities for growth and development in the SDTL role.
• Influencing internal processes related to regulatory submission work and promoting awareness of internal and external policy communications within the oncology TA and regulatory landscape. This role requires an inventive mindset to develop ideas and implement solutions that drive transformational change.
• Working alongside the Acceleration pillar within the CoE, supporting acceleration initiatives related to the SDTL role, helping to drive the SDTL role forward and adapt to new technologies and changing business needs. This role requires a creative thinker who can develop innovative strategies to streamline submissions and improve efficiency.

Other key ARAD responsibilities include:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
  • Submission delivery strategy of all dossiers and all application types per market and /or region
  • Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Support operational, quality and compliance activities for assigned deliverables
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.

Highlight the Skills and Capabilities Needed

Minimum requirements

• Relevant University Degree in Science or related discipline
• Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority
• Thorough knowledge of drug development
• Strong project management skills with a dynamic and inspiring presence to motivate teams and drive exceptional results
• Proficiency with common project management (e.g., MS Project) and document management systems
• Leadership skills, including experience leading multi-disciplinary project teams as a SDTL or similar role
• Experience in managing first-wave Marketing Application submissions
• Excellent written and verbal communication skills
• Cultural awareness and scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Ability to work independently and as part of a team
• Creative thinker with the ability to analyze problems, develop innovative ideas and recommend actions for continuous improvement and transformational change

Preferred requirements

• Knowledge of AstraZeneca's business and processes
• Experience in managing LCM and other complex regulatory deliverables across projects/products
• Proven ability in driving transformational change and implementing innovative solutions

Office Working Requirements

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, where dynamic and inspiring professionals drive transformational change.

Interested? Please apply by submitting your CV by COB 8th April 2026

Date Posted

23-Mar-2026

Closing Date

08-Apr-2026

Our 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.