赛诺菲
Submission Lead for Structured Data - all genders
Submission Lead for Structured Data - all genders
发布于 大约 7 小时前中层管理(经理/总监)
Frankfurt am Main, Germany
高级经验
全职员工
混合式弹性办公
不限
医疗、制药与临床研究
GMP
PMS
Leadership
Regulatory Affairs
Fmd
Idmp
Rim Systems
Structured Data
Xevmpd
AI 估算 · 60k–90k
Senior regulatory role in global pharma company, Frankfurt location, specialized skills in IDMP and RIM.
职位详情
关于这个职位
This role leads structured data submissions for Sanofi's global regulatory operations, ensuring medicinal product information is submitted in standardized formats (IDMP, xEVMPD) to health authorities. The position manages a team, oversees compliance, and drives process improvements.
最低要求
+ years in pharmaceutical industry
Minimum 3 years in regulatory affairs and/or regulatory data roles
Strong knowledge of medicinal product information and global information standards
Understanding of global regulatory environment and Regulatory Information Management (RIM) Systems
Hands-on experience with structured data submission applications and RIM systems
Fluent English (spoken and written)
工作职责
Leadership & Operations**
Lead structured data operations end-to-end, including submissions, confirmations, and responses to regulatory inquiries
Manage the complete business process from start to finish as the Business Process Owner
Lead a team of contract and hub based structured data specialists to ensure Sanofi meets all compliance requirements
Identify trends, opportunities, and risks that could cause late submissions; create action plans and escalate issues when needed
IDMP Implementation**
Support analysis and planning for transitioning from xEVMPD to IDMP systems to meet EU and global Health Authority requirements and deadlines
Lead structured data implementation across Sanofi globally, ensuring we meet quality and timeline requirements
Regulatory Compliance & Monitoring**
Monitor changes to global structured data standards (including xEVMPD, IDMP, PMS) and help implement updates quickly
Represent Sanofi in working groups with Health Authorities, industry partners, and vendors
Write responses to structured data questions from Health Authorities and work with internal teams before submission
Oversee quality control of company data before submitting to Health Authorities
Audit & Quality Support**
Provide expertise during audits and support inspection processes with required responses and reports
Execute operational strategy and provide direction to the team
Work with stakeholders to continuously improve structured data processes
Performance Management**
Monitor data quality and compliance in the submission process
Track Global Regulatory Operations Key Performance Indicators (KPIs)
Ensure KPI targets are met and report/escalate as needed
Set up and monitor service agreements with vendors and contractors
Team & Resource Management**
Manage team workload to ensure productivity and efficient resource use
Identify potential issues and project conflicts; resolve problems quickly and alert management when needed
Stay current on system operations, configurations, and business requirements
Consult with stakeholders on delays, action plans, and risks
Process Improvement & Documentation**
Maintain expertise in structured data processes and tools; ensure team does the same
Support implementation of tool changes and new system projects
Help create quality documents like SOPs, work instructions, user guides, and job aids
Work with stakeholders to identify and resolve structured data process issues
Complete other tasks assigned by the Head of Structured Data Strategy
优先资格
Knowledge of pharmacovigilance regulations preferred
Degree in Life Sciences, Information Technology, or related field preferred (not required)
Additional languages desirable
AI 洞察
优缺点分析
优点
- Work at a top global biopharma company with cutting-edge regulatory innovation.
- High visibility role impacting patient safety and global regulatory efficiency.
- Hybrid working model and comprehensive benefits package.
- Opportunity to shape IDMP implementation across the company.
- Managing complex global regulatory timelines and evolving standards.
- Leading a remote/hybrid team across different time zones.
- High level of responsibility for compliance and audit readiness.
- Experienced regulatory professionals looking for a leadership role in a global, R&D-driven organization.
缺点 / 挑战
暂无明显挑战项
角色解读
- Move into senior regulatory leadership roles (e.g., Head of Structured Data Strategy).
- Expand into broader regulatory operations or global submission management.
- Opportunity to influence industry standards through health authority collaborations.
- Lead structured data submissions (IDMP, xEVMPD) to health authorities on a global scale.
- Manage a team of specialists and oversee end-to-end business processes for regulatory data.
- Monitor regulatory changes and ensure Sanofi's compliance with evolving standards.
- Drive process improvements and represent Sanofi in industry working groups.
- Deep knowledge of pharmaceutical regulatory data standards (IDMP, xEVMPD, PMS).
- Strong leadership and team management experience in a matrix organization.
- Excellent communication and stakeholder management skills.
- Proficiency in English
- additional languages beneficial.
申请策略
- Tailor your CV to demonstrate regulatory data expertise and leadership impact.
- Prepare to discuss how you've managed complex regulatory changes and stakeholder alignment.
- Emphasize hands-on experience with IDMP, xEVMPD, and RIM systems.
- Showcase team leadership and cross-functional collaboration examples.
- Highlight any experience with health authority submissions and inspections.
- Include metrics on compliance improvement or process optimization.
- Familiarize yourself with EU IDMP implementation timelines and technical details.
- Brush up on pharmacovigilance regulations (if not already strong).
面试指南
- Use the STAR method (Situation, Task, Action, Result) for behavioral questions.
- For technical questions, explain standards clearly and give examples of implementation challenges.
- Demonstrate strategic thinking by linking regulatory work to patient safety and business goals.
- How would you lead the transition from xEVMPD to IDMP across global teams?
- Describe a time you managed a regulatory submission under tight deadlines.
- How do you ensure data quality and compliance in structured data submissions?
- Tell us about your experience with health authority inspections and audits.
- How do you motivate a remote team to meet KPIs?
职位点评
78
综合评分
Global pharma lead role with strong development prospects and good compensation, moderate lifestyle balance, and average purposive impact.
更适合这类人
Candidates motivated by career growth, leadership, and technical expertise in regulatory affairs.
表现最好
成长发展
相对薄弱
使命价值
薪资福利80
成长发展85
工作生活75
使命价值70
薪资福利
80较高
Competitive salary for senior regulatory role in a top pharma company with comprehensive benefits including healthcare, family leave, and hybrid work. Location in Frankfurt city center adds lifestyle value.
薪资信号未披露（AI估算：60K-90K/月）
福利待遇14-week paid family leave、high-quality healthcare、numerous prevention programs、coverage for long-term illness、childcare benefits
成长发展
85较高
High developmental value: global exposure, leadership of a team, opportunity to shape IDMP implementation, and engagement with health authorities. Continuous learning through regulatory changes.
技术前沿主流现代技术
技术栈IDMP、xEVMPD、RIM、PMS、FMD
成长机会mentor? not explicit、growth opportunities mentioned in 'Why choose us?'
业务类型ambiguous
工作生活
75中等
Hybrid working model with flexible hours, located in Frankfurt city center. No explicit mention of work-from-home frequency but hybrid labeled. Benefits indicate good work-life balance support.
工作模式混合式弹性办公
办公地点市区核心地段
加班情况未提及（无法判断）
工作生活平衡hybrid、flexible working time models
使命价值
70中等
Role contributes to patient safety and regulatory efficiency, but output is more compliance-focused than direct patient impact. Sanofi's mission emphasizes scientific miracles, but the role is behind-the-scenes.
行业发展稳定成熟行业
社会影响中性/一般
使命信号improving people’s lives、chase the miracles of science
创新程度积极采用新技术
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