Director Reg Strategy Oncology Daiichi Sankyo Edison

Job Description: • 2-minute read •
This position independently leads the preparation, alignment and formulation of strategy for EU regulatory submissions and may assist with global regulatory submissions. This position acts as point of contact for interactions with Health Authorities (HA) and cross-functional team members (US or global) and may lead team(s) in orchestrating complex EuropeanHealth Authority interactions. This position fosters a global view on cross-functional teams and mentors and provides guidance to junior RA representatives.

This position provides regulatory advice internally and/or externally. Additionally, this position interacts with RA team members both regionally and globally, cross-functional team members, EMEA Project Managers and/or Reviewers and may interact with ex-US Health Authorities. This position works often with moderate level of ambiguity and complex problems and focuses on strategic rather than tactical decisions. This position leads the more complex regulatory activities and is increasingly involved in complex and/or global projects. This position works with a high level of independence and autonomy, has a high degree of latitude to manage workload, takes initiative and defines direction without needing guidance. This position acts as a coach to junior staff and motivates self and others to complete projects on time. This position exercises significant latitude and independence in assignments.

Responsibilities

Maintains a high level of regulatory knowledge and provides regulatory advice.

Acts as single point of contact to EMEA for more complex products/projects. Liaises, negotiates and leads EMEA interactions, including appropriate documentation of interaction, decisions and outcomes with oversight from supervisor.

Independently leads the preparation, coordination or monitoring of US regulatory submissions; may assist with global regulatory submissions. Interacts across Daiichi Sankyo to obtain and/or provide information/data for regulatory submissions.

Leads the formulation of registration strategies for products/projects. Ensures US and/or global registration strategies are outlined in GRASP. Ensures registration strategies adhere to corporate objectives.

Provides US RA representation on project teams; may lead regulatory sub-team. May act as single point of RA contact on cross-functional teams; fosters a global view as a member of the regulatory team.

Mentors and provides guidance to junior RA representatives.

Travel 15%

Qualifications:

B.S. degree, preferably in a scientific discipline
Prefer an advanced degree (e.g., Masters, Pharm.D., Ph.D.)
Experience in the pharmaceutical industry required with 8-10 years direct regulatory affairs experience, including US regulatory experience

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