Regulatory Affairs Portfolio Director

Would you like to apply your Regulatory Affairsexpertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most innovative technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. 

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.

Key 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 groundbreaking RAM capabilities as well as system and process improvement driving productivity gains. Influence the image of the business externally.

Within a drug project leadership role, 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 objectives 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,

• 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 knowledge sharing of best practice through coaching and mentoring across the RAM community

Minimum Qualifications:

• A Master's Degree in regulatory or science related field. A solid knowledge of regulatory affairs or regulatory management in early and late development
• 5 years of 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
• Proven successful leadership and project management experience
• Proven ability 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

Desired Qualifications:

• Experience in Oncology (small molecules & biologics)
• Knowledge of AZ business and processes.
• Facilitation skills
• Resource management

Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering innovative methods and bringing unexpected teams together. Interested? Come and join our journey.

Where can I find out more?
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/  
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/   
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en 

The annual base pay for this position ranges from $186,232.80 to $279,349.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.