Associate Regulatory Affairs Director I
JOB TITLE: ASSOCIATE REGULATORY AFFAIRS DIRECTOR I
CAREER LEVEL: E
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..
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
What you’ll do
As a member of the RIMS change release management team you will be responsible for the planning, coordination, monitoring and delivery of agreed system and configuration releases within the RIM / ERV (Enterprise Regulatory Vault) platform. ERV is AstraZeneca's business-wide system for Regulatory Information Management (RIM).
Specific responsibilities include:
Creating, refining, prioritizing and agreeing business requirements
Ensuring proposed solutions address requirements and deliver business benefits
Managing and conducting User Acceptance Testing (UAT) during configuration and for continuous improvement (CI) releases
Anticipating, documenting and addressing (or mitigating) program issues and risks in a timely, efficient and effective manner, and where appropriate, are escalated to Product Owners and Strategic Product Director
Partnering with Training, Change and Communications lead to ensure training and user support materials are assessed and updated in support of releases, and to manage business-focused project communications.
Essential for the role
Bachelor’s degree or equivalent experience within the pharmaceutical or IT industries.
Experience of delivering projects across the global enterprise and operating in a complex environment with multiple stakeholders, particularly with a significant IT component.
Experience in agile delivery of business applications to a globally distributed user base
Good understanding of current system development lifecycle methodologies.
Awareness of current developments in the pharmaceutical industry and global regulatory environment in the electronic submission arena (evolving regulatory information standards, processes and technology).
Knowledge of regulatory documentation, submissions, publishing and approval processes
Desirable for the role
Professional qualification in project/programme management or a proven record of successful project management/delivery, particularly at the business/IT interface.
Experience of delivering enhancement projects for a GxP, ER/ES or other ‘regulated’ system.
Experience managing multiple stakeholders in a globally diverse and cross-cultural environment
Expertise in assessment and management of risk
Track record of building relationships across, cultures, functions and disciplines to achieve delivery
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.
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.