Associate Director Regulatory Affairs Strategy - Basking Ridge , New Jersey, United States, 07920
Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.
This position assists in the preparation, supports the alignment and assists with the formulation of strategy for EU regulatory submissions with some supervision. This position may act as point of contact for interactions with Health Authorities (HA) and RA team members and cross-functional team members with managerial support. This position may be responsible for routine EMEA interactions with minimal supervision. This position maintains a moderate to high level of regulatory affairs knowledge. This position works often with a lower level of ambiguity and less complex problems, works on both strategic and tactical issues and works independently with minimal supervision. This position leads routine submissions and/or interactions and is increasingly involved in global or more complex projects with oversight by manager. This position works with a moderate independence and autonomy and has latitude to manage workload within established limitation and decision-making authority.
Maintains a high level of regulatory knowledge.
Acts as single point of contact to EMEA for assigned products/projects. Liaises with EMEA project manager/reviewers to resolve any potential issues with minimal supervision. Responsible for the appropriate documentation of interaction, decisions and outcomes.
Leads the preparation, coordination or monitoring of Ex US and US regulatory submissions with supervision.
Interacts across Daiichi Sankyo to obtain and/or provide information/data for regulatory submissions.
Assists in or leads the formulation of registration strategies for products/projects, depending on complexity.
Provides EU RA representation on project teams. May act as single point of RA contact on cross-functional teams with managerial oversight; begins to foster a global view as a member of the regulatory team.
- 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 5+ years direct regulatory affairs experience, including ex US regulatory experience
Associate Director Regulatory Affairs Strategy
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