Regulatory Information Manager AstraZeneca

Job description
Regulatory Information Manager AstraZeneca

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).

As an industry-leading Oncology Regulatory function, we drive efficiency and innovation to bring medicines to patients as quickly as possible. It’s by delivering rapid and global approvals, that we play our part in turning meaningful innovation in drug development strategies into reality. We play a key role in making sure our transformative science born in labs will be transformed into real value for patients.

Collaboration and learning are a big part of how we work and how we win. Within Regulatory we work together across our locations, therapy areas and external community to share learnings and knowledge. It means we are proactive self-starters, comfortable stepping up and taking ownership to enhance our personal and professional development.

We are all compassionate team players and driven achievers, always ready to step up. We are now looking for you who recognise yourself in this and want to join us taking on the Manager Regulatory Information role.

This is a consulting assignment with Randstad Life Sciences. 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. 

Responsibilities
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).

Main 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.


Qualifications
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

So, what’s next?
Are you already imagining yourself in this position? Good, because we can’t wait to hear from you!

About the company
Deadline: 2023-08-04, 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:
Please contact Maria del Carmen, maria.leiva@randstad.se

about randstad life sciences.
Randstad Life Sciences is specialized in competencies 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 activities.

With more than 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry and offers staffing, consulting and recruitment solutions in all areas of expertise. We also offer interim management, executive search and outplacement services. We have a broad network of clients and candidates, which means we convey hundreds of jobs within different industries all over Sweden. Our ambition is to be the best employer in the market.

By combining our passion for people with the power of today’s technology, we help people and organizations to reach their true potential. We call it Human Forward.