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Do you have experience of working with Regulatory Information and would like to work in a global team?
Hays Life Science is now searching for a Regulatory Information Manager to join a Global Pharmaceutical Company in Gothenburg, Sweden.
This is a consulting assignment.
Your new role
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 in taking on the Manager Regulatory Information role.
What you'll do
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 manages 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 the 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.
Essential for the role
- University degree in the life sciences or equivalent experience in the pharmaceutical/medical industry
- Knowledge of the 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
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion of your career.
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