Regulatory Information Manager, AstraZeneca Gothenburg

Job description
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.

The Arena:
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


Responsibilities
The role:
The Manager, Regulatory Information 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.


Qualifications
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

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-01-13, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Birgitta Nyström, birgitta.nystrom@randstad.se

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!