Job Title :Regulatory Affairs Group Director
Career Level : F
Lead the way for a new breed of solutions-oriented Regulators
Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development
Be part of the team where you are empowered to follow the science
Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..
ABOUT ASTRAZENECA
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development
ABOUT THE TEAM
We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.
ABOUT THE ROLE
Job Description / Capsule
Responsible for recruitment and line management of 10+ regulatory professional staff. Contribute to the strategy, direction and efficient operation of the Regulatory TA organisation as well as the RAM community. Provide regulatory expertise and oversight to ensure high quality drug project operational delivery and efficiency by the group.
Take on responsibility as subject matter expert to drive continuous improvement or change project.
Typical Accountabilities
Provide leadership, coaching and line management for 10+ 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 member of the Leadership Team for the TA Regulatory Affairs Management (RAM) 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 CMO) 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.
Education, Qualifications, Skills and Experience
Essential
University Degree in Science or a related discipline
Minimum of 12 years of regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing and of working across a range of markets, including regulated markets
Extensive 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
Desirable
Managed first wave Marketing Application and/or LCM submissions
Managed complex regulatory deliverables across projects/products
Knowledge of AZ business and processes.
Facilitation skills
WHY JOIN US?
We believe there’s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.
Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
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.