Associate Regulatory Affairs Director

The Associate Regulatory Affairs Director (ARAD) plays a central role in turning transformative science into approved medicines for patients with unmet medical needs. This position leads end-to-end planning, coordination and execution of regulatory deliverables, shaping submission strategies, anticipating risks and opportunities, and driving applications through to approval. Working across regions and functions, the ARAD provides clear regulatory guidance to project teams, helps navigate complex procedures for small and large molecules, and ensures that regulatory execution keeps pace with an ambitious and evolving portfolio. Ready to influence how breakthrough therapies reach patients faster?

Accountabilities

• Lead the development and delivery of regulatory submission strategies for assigned products and markets, understanding regional frameworks, trends and requirements for all relevant application types.

• Provide expert guidance on procedural and documentation requirements defined by Health Authorities, including submission delivery strategies, document review and input, and analysis of regulatory procedures and special designations across the product lifecycle.

• Drive the planning, preparation, authoring (where relevant) and delivery of both simple and complex submissions from a global and/or regional perspective, ensuring quality, timeliness and alignment with strategic objectives.

• Lead GRST and GRET sub-teams, acting as a key driver for cross-functional Submission Delivery teams for major submissions such as NDA/MAA or significant lifecycle management initiatives.

• Develop, execute and maintain robust submission delivery plans and submission content plans, proactively communicating status, issues and changes to designated stakeholders.

• Coordinate input, maintenance and revision of Planit project plans for assigned projects, highlighting unforeseen changes in resource demand in a timely manner to the Lead RPM and line manager.

• Identify regulatory risks early, propose mitigation strategies and communicate them effectively to Lead RPMs and cross-functional teams.

• Support operational and compliance activities for assigned deliverables, including generation of work requests and submission content plans, tracking, TMF oversight and document management, working closely with GRO, Marketing Companies, CROs and alliance partners.

• Build strong relationships with Health Authorities and Marketing Companies as required, managing routine and non-routine interactions to support submissions and approvals.

• Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management (RAM) skill group, contributing actively to capability building.

• Contribute to continuous process improvement initiatives that enhance regulatory execution, efficiency and quality.

• When assigned Lead RPM responsibilities, lead the Global Regulatory Execution Team (GRET), holding overall accountability for project management of all GRET deliverables.

• Act as a key member of the Global Regulatory Strategy Team (GRST), focusing on delivering GRST product plan submission milestones through operationally efficient submission delivery plans.

• Identify regulatory risks and risk mitigation strategies for GRET executions and deliverables, incorporating input from all team members.

• Drive GRST and GRET resourcing processes, support fee forecasting activities and allocate RAM resources to GRET deliverables.

• Liaise closely with Global Project Management (GPM) and other functional project managers to ensure alignment of plans, timelines and priorities.

• Serve as a go-to person for RAM project guidance and support, facilitating knowledge sharing and development within and between GRET and GRST.

• When assigned Market Contact responsibilities, develop, maintain and provide RAM with clear, concise and timely guidance on current priorities and regulatory requirements for assigned markets/regions to support project deliverables and business decision-making.

• Drive market/region knowledge sharing with key stakeholders through targeted meetings, networking and communications to maintain regulatory consistency and right-first-time submissions.

• Build strong two-way relationships with Marketing Company staff in assigned markets/regions to support effective interpretation of regulatory requirements related to RAM deliverables.

• Coordinate gathering of documentation to support tenders and oversee general regulatory compliance in assigned markets/regions, escalating any compliance issues appropriately.

Essential Skills/Experience

· 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

· Leadership skills, including experience leading multi-disciplinary project teams

Desirable Skills/Experience

· Managed first wave Marketing Application and/or LCM submissions

· Managed complex regulatory deliverables across projects/products

· Knowledge of AZ Business and processes

Skills and Capabilities

· Excellent written and verbal communication skills

· Cultural awareness

· Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions

· Proficiency with common project management (e.g., MS Project) and document managementtools

· Ability to work independently and as part of a team

· Influencing and stakeholder management skills

· Ability to analyze problems and recommend actions

· Continuous Improvement and knowledge sharing focused

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.

At AstraZeneca, Regulatory Affairs professionals are empowered to shape how innovative medicines reach patients worldwide, working at the forefront of science to secure rapid global approvals for therapies that address real unmet needs. Collaboration across disciplines, locations and external partners is encouraged to solve complex challenges in novel ways, supported by an inclusive culture that values diverse perspectives, continuous learning and smart risk-taking. With a rich pipeline spanning the full drug development journey, there is scope to grow skills, explore different roles and act as an agent of change while helping transform breakthrough research into meaningful impact for patients.

If this role matches your experience and ambition, apply now to help drive life-changing medicines towards those who need them most.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.