Regulatory Affairs Project Director

The Regulatory Affairs Project Director (RAPD) is an experienced regulatory specialist with strong project management capabilities who takes on critical leadership roles for particularly complex and high priority global regulatory projects and / or major submissions. Typical capabilities for the RAPD are; to develop and maintain successful strategic and collaborative relationships, to proactively influence and negotiate across local and global teams and to independently resolve issues and drive accelerated delivery plans.

The RAPD provides regulatory expertise and guidance on procedural and documentation requirements to all stakeholders and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. The RAPD  may also lead continuous improvement, transformation and critical business development projects, driving initiatives for efficiency and productivity across the business.

Your responsibilities could include, but are not limited to:

• Drive and lead delivery focused teams, e.g., GRET (Global Regulatory Execution Team),  RSDT (Regulatory Submission Delivery Team). Assume overall accountability for the planning, forecasting and reporting, utilising refined project and stakeholder management skills, ensuring optimised delivery of regulatory activities to time and quality.
• Be a  core member of strategy teams, e.g. GRST (Global Regulatory Strategy Team) and RSST (Regulatory Submission Strategy Team), successfully collaborating with key stakeholders, challenging and contributing to ensure optimised delivery of regulatory strategy plans from  Candidate Drug (CD) nomination through to submissions and approval to achieve critical milestones and scorecard goals.
• Ensure all compliance activities for the project/product are completed and maintained.
• Identify regulatory risks, opportunities and proactively develop mitigation strategies for operational regulatory activities, e.g. planned submissions, (with input from all team members).
• Facilitate stakeholder management and communication within Regulatory, cross functionally and across collaborations.

As a senior member of the RAM community, the RAPD will:

• Be a recognised expert in the current regulatory environment. Understand the regulatory framework, including regional trends for various types of applications, procedures and documents, in both small and large molecules with a particular focus on planning, delivery and project management.
• Be a recognized expert in the AZ Regulatory Operating Model and AZ Drug Development Process
• Be a visible, approachable leader and role model for the whole RAM community.
• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of key regulatory activities, e.g. major submissions throughout the product’s life cycle from a global and/or regional perspective.
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Be a role model for AZ Values & Behaviours: personally driven to improve standards across the business, drive and lead continuous improvement and knowledge sharing of best practice through coaching and mentoring across the RAM community.

Essential

• University degree in science or a related discipline.
• Extensive regulatory experience within the biopharmaceutical industry, or combined with experience at a health authority
• Knowledge of regulatory procedures and legislation for drug development, throughout the product lifecycle
• Managed first wave Marketing Application/Line Extension and/or LCM submissions, as a Submission Delivery Team Lead (SDTL).
• Managed complex regulatory deliverables across projects/products.
• Thorough knowledge of drug development.
• Proven successful leadership and strong project management experience and skills.
• Strong influencing, stakeholder management and negotiating skills.
• Proficiency with common project management tools  and methodology.
• Excellent written and verbal communication skills.
• Team facilitation