Manager Global Regulatory Affairs

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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA with the following requirements: Bachelor degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related field plus 3 years of related experience. Prior experience must include: Vendor and Client Management for Regulatory Operations - Manage relationships with vendors and clients for various regulatory operations services; Identify and evaluate potential eCTD submission vendors based on their experience, expertise, cost-effectiveness, and track record to finalize a suitable vendor; Regulatory Analysis -Analyze the regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC and post-marketing phase for synthetic and botanical drugs; Regulatory submissions to US FDA, EU, Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery of detailed and accurate regulatory submissions for drugs, biologics (for US FDA) and Class I-IV devices (for US FDA, Health Canada, EU, and other international agencies) by collaborating with regulatory leads, RPMs, publishers, RIM team, medical writers, and functions SMEs; Regulatory system and business process expertise- Write, develop, and deliver effective regulatory system training programs, work instructions, user guides, SOPs that are tailored to the needs of the regulatory leads and that effectively communicate the regulatory requirements and guidelines in practice. Up to 30% domestic travel required. Up to 70% remote work allowed.

Full time. $165,500 - $186,000/year

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