Group Director Regulatory Process- Cell Therapy

AstraZeneca • Gaithersburg, MD

4d • Hybrid

About The Position

This role covers a combination of line management, drug project leadership and cross-project responsibilities. The proportion of each element which is expected at any one time, will vary between individuals and will be adjusted for an individual depending on workload and to meet business and portfolio needs. As a line manager an individual is responsible for recruitment and line management of 4-20 regulatory professional staff. In addition, they will contribute to the strategy, direction and efficient operation of the Regulatory TA organisation as well as the RAM community. They will also provide regulatory expertise and oversight to ensure high quality drug project operational delivery and efficiency by the group. As an experienced regulatory specialist with strong project management capabilities, an individual can also take on critical leadership roles for particularly complex and high priority global regulatory projects and / or major submissions. Typical capabilities required 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. In addition, they will provide 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. In addition, an individual can also take on responsibility as subject matter expert to drive continuous improvement or change project.

Requirements

• Bachelors degree in Science or a related discipline
• 5+ years 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
• Shown successful leadership and project management experience
• Proven track record 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
• Proficiency with common project management tools and methodology.
• Managed first wave Marketing Application and/or LCM submissions
• Managed complex regulatory deliverables across projects/products

Nice To Haves

• Knowledge of AZ business and processes.
• Facilitation skills
• Resource management

Responsibilities

• As a line manager, provide leadership, coaching and line management for 4-20 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 leader within the TA Regulatory group, proactively contribute to the strategy, direction and efficient operation of the group.
• Develop and deliver departmental performance targets for the TA Regulatory organisation.
• Assignment of capable RAM resources to meet the drug project and improvement project needs in collaboration with the wider Regulatory TA leadership team and Lead RPMs, ensuring cost effective and flexible resource management which is aligned with TA priorities and specific Global Regulatory Execution Teams(s) (GRET(s)) as required.
• 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 and GRETs adheres to and remains in compliance with AZ standards, processes, AZ group policies and corporate responsibilities.
• Has an in-depth regulatory knowledge and understanding of RAM roles, Submission Excellence and Regulatory Operating Model and can support individuals as needed with typical 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 and/or drug project work.
• Collaborate with the wider global regulatory organisation (cross TA and centrally) to drive the development of leading-edge RAM capabilities as well as system and process improvement driving productivity gains.
• Influence the image of the business externally.
• 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.
• Be a recognized 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

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior