Purpose of the function

Accountable for the performance of Regulatory Intelligence and Policy in the EU and the achievement of internal and external deliverables by providing regulatory intelligence and information management and effective communication and reviewing and interpreting regulatory and scientific regulations, directives, guidelines and initiatives. Overall management of Regulatory Intelligence for DSE using publicly available or internal information sources, paid databases in access and networking (e.g. vfa, efpia). Communicate important changes and trends within Regulatory Affairs, working with counterparts in Regulatory Intelligence in other regions as well as with other internal functions when required.

Roles and Responsibilities

• Planning tasks: Represent EU Regulatory Intelligence collaborating with US, Japan and other counterparts in Global Regulatory Affairs to identify and anticipate key regulatory trends of relevance emerging from the EU region or affecting the EU and global business and Daiichi Sankyo development activities
• Decision tasks: Inform regulatory management of current and future developments in the regulatory environment and agree impact on Daiichi-Sankyo business and its current practices. Develop guidance and mitigation strategies to mitigate risks and maximize opportunities for Daiichi-Sankyo’s business. As assigned by manager, analyze current available regulatory guidance and intelligence based on current, new and evolving EU regulatory requirements for certain therapeutic areas (e.g. oncology, rare disease, cardiovascular etc.) and identify regulatory risks and opportunities for products assessed in the Due Diligence process at Daiichi Sankyo, including advise on how to mitigate risks from EU perspective
• Executive tasks:
  • Advise regulatory professionals and proactively manage all aspects of Regulatory Intelligence both internal and external to DSE: Conduct or oversee the Regulatory Intelligence activities in the region and provide regular over views of the current and emerging regulatory developments using e.g. newsletters, presentations as well as on special communication issues, whereappropriate.
  • Draft and revise SOPs and SOIs, if required for management review.
  • Develop a formal process for reviewing and submitting comments on draft regulatoryand scientific guidance documents and submit in agreement with manager togovernments, regulatory health agencies and committees, enabling Daiichi-Sankyovoice to influence and shape future regulatory legislation, guidelines and policy.
  • Support training needs of associates/managers in Regulatory and provide regulatoryeducation on EU guidance and procedures working with counterparts globally, people’smanagers and other functions in the department such as Procedural Management andClinical Trial Offices.
  • As assigned by manager, support Business Development function during DueDiligence process providing EU regulatory expertise and Regulatory Intelligence asrequested.Leadership tasksLead interdisciplinary teams to discuss in depth relevant legislation and scientific guideline developments and identify risks and opportunities of particular interest to Daiichi Sankyo, manage any commenting process and external communication process.
• As agreed with regulatory management, lead and represent Daiichi Sankyo interacting with EU trade associations and interest groups.

Skills and additional Requirements

• Knowledge of Medical Devices/In-vitro diagnostics is recommended.
• Excellent interpersonal skills.
• Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
• Be “detailed-oriented” with a good oversight, well organized and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects. High ethical behavior.
• High Computer proficiency (e. g. MS office, document management systems and databases).
• Excellent written and verbal communication skills in English and German, a third language would be preferred.