Country: Hungary
Functional area: Regulatory Affairs
Our innovative pharmaceutical partner is seeking a new team member for an exciting position within their international organization, specifically in the regulatory field.
The ideal candidate will bring experience in regulatory affairs and will support and drive the initiation of complex international projects across Regulatory Affairs and Pharmacovigilance. This role involves close collaboration with reporting and data management teams. Embrace data-driven insights to enhance pharmaceutical product evaluations and drive impactful outcomes. Harness data complexity to support strategic decision-making and elevate the Global Regulatory Science organization. Strengthen their Center of Excellence by developing robust analysis competencies, empowering regulatory professionals to uncover trends and insights that shape future strategies.
The ideal candidate will bring experience in regulatory affairs and will support and drive the initiation of complex international projects across Regulatory Affairs and Pharmacovigilance. This role involves close collaboration with reporting and data management teams. Embrace data-driven insights to enhance pharmaceutical product evaluations and drive impactful outcomes. Harness data complexity to support strategic decision-making and elevate the Global Regulatory Science organization. Strengthen their Center of Excellence by developing robust analysis competencies, empowering regulatory professionals to uncover trends and insights that shape future strategies.
Key Responsibilities
- Lead and implement initiatives focused on optimizing global regulatory and safety processes, leveraging process improvement methodologies.
- Analyze operational data (e.g., cost, capacity, KPIs) to identify performance gaps and propose actionable solutions.
- Design and maintain regulatory process flowcharts, conduct gap analyses, and document process improvements.
- Collaborate closely with Business Intelligence and Data Management teams to translate regulatory needs into data-driven initiatives.
- Actively engage stakeholders across departments and geographies to align improvement strategies with organizational goals.
- Initiate and manage international projects that enhance regulatory operations and compliance outcomes.
- Track and evaluate process performance using KPIs, ensuring alignment with continuous improvement goals.
Support training and knowledge-sharing activities to promote a culture of process excellence across the regulatory organization.
Requirements
Education & Language
- Master’s degree in Life Sciences, Business Administration, Process Management, or a related discipline.
- Fluency in English, both written and spoken, is required.
- Experience in regulatory affairs or pharmacovigilance within the pharmaceutical industry.
- Proven track record in business process improvement or operational excellence roles.
- Strong understanding of regulatory operations and compliance within a global context.
- Exposure to cross-functional collaboration, particularly with data or BI functions.
- Prior experience working in a regulated, data-intensive environment is highly desirable.
- Proficiency in data analytics tools and the ability to interpret complex regulatory data.
- Experience in creating and presenting clear, actionable visual reports and dashboards.
- Strong analytical thinking, problem-solving ability, and strategic mindset.
- Excellent interpersonal and stakeholder management skills.
- A digital-first mindset with a passion for driving transformation.
- Familiarity with process excellence methodologies (e.g., Lean, Six Sigma).
- Project leadership experience in process optimization initiatives is an asset.
- Knowledge of RIM tools such as Veeva Vault is considered a plus.
Our innovative pharmaceutical partner is seeking a new team member for an exciting position within their international organization, specifically in the regulatory field.
The ideal candidate will bring experience in regulatory affairs and will support and drive the initiation of complex international projects across Regulatory Affairs and Pharmacovigilance. This role involves close collaboration with reporting and data management teams. Embrace data-driven insights to enhance pharmaceutical product evaluations and drive impactful outcomes. Harness data complexity to support strategic decision-making and elevate the Global Regulatory Science organization. Strengthen their Center of Excellence by developing robust analysis competencies, empowering regulatory professionals to uncover trends and insights that shape future strategies.
The ideal candidate will bring experience in regulatory affairs and will support and drive the initiation of complex international projects across Regulatory Affairs and Pharmacovigilance. This role involves close collaboration with reporting and data management teams. Embrace data-driven insights to enhance pharmaceutical product evaluations and drive impactful outcomes. Harness data complexity to support strategic decision-making and elevate the Global Regulatory Science organization. Strengthen their Center of Excellence by developing robust analysis competencies, empowering regulatory professionals to uncover trends and insights that shape future strategies.
Key Responsibilities
- Lead and implement initiatives focused on optimizing global regulatory and safety processes, leveraging process improvement methodologies.
- Analyze operational data (e.g., cost, capacity, KPIs) to identify performance gaps and propose actionable solutions.
- Design and maintain regulatory process flowcharts, conduct gap analyses, and document process improvements.
- Collaborate closely with Business Intelligence and Data Management teams to translate regulatory needs into data-driven initiatives.
- Actively engage stakeholders across departments and geographies to align improvement strategies with organizational goals.
- Initiate and manage international projects that enhance regulatory operations and compliance outcomes.
- Track and evaluate process performance using KPIs, ensuring alignment with continuous improvement goals.
Support training and knowledge-sharing activities to promote a culture of process excellence across the regulatory organization.
Requirements
Education & Language
- Master’s degree in Life Sciences, Business Administration, Process Management, or a related discipline.
- Fluency in English, both written and spoken, is required.
Professional Experience
- Experience in regulatory affairs or pharmacovigilance within the pharmaceutical industry.
- Proven track record in business process improvement or operational excellence roles.
- Strong understanding of regulatory operations and compliance within a global context.
- Exposure to cross-functional collaboration, particularly with data or BI functions.
- Prior experience working in a regulated, data-intensive environment is highly desirable.
Skills & Competencies
- Proficiency in data analytics tools and the ability to interpret complex regulatory data.
- Experience in creating and presenting clear, actionable visual reports and dashboards.
- Strong analytical thinking, problem-solving ability, and strategic mindset.
- Excellent interpersonal and stakeholder management skills.
- A digital-first mindset with a passion for driving transformation.
- Familiarity with process excellence methodologies (e.g., Lean, Six Sigma).
- Project leadership experience in process optimization initiatives is an asset.
- Knowledge of RIM tools such as Veeva Vault is considered a plus.
If you are interested in this position, please submit your CV through the advertisement. Our colleagues will contact you with further details.