Associate Director, Regulatory Affairs Vaccines CMC

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Job Description

OBJECTIVE / PURPOSE

• Provides program leadership and develops CMC regulatory strategy in support of global vaccine programs in various stages of development 

• Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data are identified, obtained and effectively presented for the registration and maintenance of vaccine licenses world-wide 

• Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges that arise during vaccine product development and commercialization 

• Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly. 

ACCOUNTABILITIES

• Leads planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed 

• Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization 

• Leads regulatory compliance assessments with respect to filing requirements for assigned vaccines and/or changes throughout development and the commercial life cycle 

• Defines CMC strategy and content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements 

• Supports CMC preparation activities for meetings with Health Authorities on CMC related matters as needed.  Interacts directly with international Health Authorities, as required.  Participates in and/or leads agency meetings on CMC topics 

• Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner 

• Stays up to date with current and evolving