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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.
SUMMARY: 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
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Job Title Associate Director Regulatory Affairs Strategy
City Basking Ridge
Functional Area Regulatory Affairs Oncology
State New Jersey Associated topics: administrative, administrative staff, asso, beverage, chief operations officer, facilities, operation, operational assistant, operational support, support
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.