Regulatory Information Manager at AstraZeneca

We are seeking a Regulatory Information Manager for an exciting assignment at AstraZeneca in Gothenburg!

Do you have experience of working with Regulatory Information and would like to work in a global team environment? Are you interested in a new challenge in the ever-changing environment called RIM (Regulatory Information Management)? Then this role is something for you! We are now looking for a Regulatory Information Manager to join us in Global Regulatory Operations (GRO) at AstraZeneca in Gothenburg.

Purpose, Offer and Benefits

This is a consulting assignment that will run until 2023-05-04. This means that you will be employed by TNG during this time. 

At AstraZeneca, we are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Your Responsibilities

• Represents and manage the interface between Global Regulatory Operations (GRO) delivery units and early as well as late stage drug projects.
• Collaborates with GRO teams and partners to assure efficient delivery of end to end Regulatory Information Management.
• Manage and govern the regulatory data for assigned areas of responsibilities in accordance with regulatory data standards, business processes and regulatory requirements.
• Compiles and delivers XEVMPD, IDMP or other regulatory data submissions to health authorities.
• Develops self in topic areas critical to successful delivery of the RIM remit. Particularly, technical skills and knowledge of international regulations.
• Engages with partners, affiliates, or other customers and stakeholders to manage regulatory data 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.
• Subject matter expert in the management, analysis and quality control of regulatory data standards and regulatory information.

The Bigger Picture

The Regulatory Information Manager is responsible for supporting the management, collection, creation and analysis of regulatory data and regulatory information. The Regulatory Information Manager is an expert in end-to-end Regulatory Information Management (dossier format, publishing, tracking).

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world´s most serious diseases.

Our Expectations

Essential for the role:

• University degree in the life sciences or equivalent experience in pharmaceutical/medical industry
• Knowledge of pharmaceutical drug development process
• Strong analytical and critical thinking ability

Desirable for the role:

• 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