Purpose of the function

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 overviews of the current and emerging regulatory developments using e.g. newsletters, presentations as well as on special communication issues, where appropriate.
  • Draft and revise SOPs and SOIs, if required for management review.
  • Develop a formal process for reviewing and submitting comments on draft regulatory and scientific guidance documents and submit in agreement with manager to governments, regulatory health agencies and committees, enabling Daiichi Sankyo voice to influence and shape future regulatory legislation, guidelines and policy.
  • Support training needs of associates/managers in Regulatory and provide regulatory education on EU guidance and procedures working with counterparts globally, people’s managers and other functions in the department such as Procedural Management and Clinical Trial Offices.
  • As assigned by manager, support Business Development function during Due Diligence process providing EU regulatory expertise and Regulatory Intelligence as requested.
• Leadership tasks: Lead 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.

Education

• University Degree (Bachelor, Master, State Examination, Diploma) in Pharmacy, Medicine, Life or Natural Science is required; PhD preferred.

• Post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master Degree in Regulatory Affairs or further pharmaceutical specialization (e.g. “Fachapotheker für Arzneimittelinformation”) is preferred.

Work Experience

• Regulatory Intelligence function, in review commenting process e.g. with new legislative proposals or new/revised guidelines.
• 8 to 11 years experience working in Pharmaceutical Industry, Clinical Research Organizations or in a regulatory health authority with at least 5 to 8 year experience in Regulatory Affairs with an emphasis on clinical trial applications, regulatory pre-submission and post-approval activities and preparation of new Marketing Authorization in Europe (EU and non-EU).
• Experience in paediatric development is preferred.
• 8 to 11 years experience of working in a European or global regulatory environment and interacting with regulatory authorities.
• Deep knowledge of European laws, regulations, guidelines and other requirements for human medicinal product marketing authorization and maintenance is essential.

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.
• 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.