Regulatory Information Manager

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Global Regulatory Operations (GRO) manages several parts of Regulatory Information Management (RIM) within AstraZeneca. GRO has the expertise and provide the tools and services to be able to meet:

• The ever-increasing complexity of regulations and product portfolios
• Growing demand for data due to increased public and regulatory scrutiny
• Global collaboration and standardization of formats and processes across the markets
• Increased use of partners and outsourcing

About the position
The Regulatory Information Manager is primarily responsible for supporting the management, collection, coding and analysis of AstraZeneca regulatory information, the Global Product Registration List and regulatory data standards such as XEVMPD and IDMP.
Typical Accountabilities:
• Manages the collection, coding and analyses of regulatory information for assigned products in accordance with regulatory data standards, quality control and quality improvement methodologies.
• Compiles and delivers XEVMPD or other regulatory information-based submissions to health authorities.
• Develops self in topic areas critical to successful delivery of the RI remit. Particularly, technical skills (XEVMPD, IDMP), knowledge of international regulations and skills (communication, project management).
• Engages with partners, affiliates, subsidiaries or other stakeholders to collect regulatory information and to ensure compliance with procedures and standards.
• Monitors the environment for changes in legislation related to regulatory information.
• Reviews and evaluates regulations, guidelines and technical specifications related to regulatory information processes and regulatory information data standards.
• Identifies opportunities for continuous improvement.
• Prepares business reports or alerts in response to business or health authority request.
• Ensures collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes and regulatory data standards.

Your profile
Minimum requirements
• University degree in the life sciences or IT
• Experience in pharmaceutical/medical industry
• Knowledge of pharmaceutical drug development process
• Strong analytical and critical thinking ability
• Good understanding of current regulatory legislation, guidelines and trends relating to regulatory information (process, tools, standards)
• Able to manage productivity responsibilities

Preferred experience and key factors
• Good problem and conflict resolution skills
• Ability to set and manage priorities, performance targets and project initiatives
• Ability to innovate best practices with business process analysis and design
• Ability to thrive in a rapid paced environment

About the organisation
This position is a consultant assignment at AstraZeneca via QRIOS Life Science & Engineering in Göteborg for one year. During this time you will be employed by QRIOS Life Science & Engineering.
QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER

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 are opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.