Takeda Digital Ventures
Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (S
Takeda Digital Ventures, Boston, Massachusetts, us, 02298
Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director)
Join Takeda Digital Ventures as the
Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) . Takeda's Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming patient lives worldwide through innovative plasma-derived therapies. With over 80 years of experience in developing treatments for rare and complex diseases, we offer a broad portfolio of plasma medicines and care solutions across more than 80 countries, supported by approximately 17,000 employees, 230 BioLife donation centers, and state-of-the-art manufacturing facilities. This role involves overseeing global regulatory operations within PDT, ensuring compliance, process excellence, and strategic leadership in regulatory submissions and relationships with third-party vendors. Key Responsibilities:
Strategic oversight of global regulatory submissions for PDT products, ensuring timely and well-resourced execution. Lead global compliance initiatives and process improvements across the organization. Manage relationships with external vendors and collaborate with R&D and other functions on regulatory strategies. Provide leadership within the PDT Regulatory Affairs leadership team, influencing strategic, portfolio, and operational decisions. Qualifications:
Bachelor's degree required; scientific field preferred. 7-10 years of regulatory experience in pharma/biotech, with management experience. Expertise in global drug development regulations, submissions, and lifecycle management. Additional Information:
This position is based in Boston, MA, with a hybrid work model. The salary range is $208,200 - $327,140, complemented by comprehensive benefits including incentives, insurance, and retirement plans. Takeda is committed to diversity and equal opportunity in all aspects of employment. #J-18808-Ljbffr
Join Takeda Digital Ventures as the
Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) . Takeda's Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming patient lives worldwide through innovative plasma-derived therapies. With over 80 years of experience in developing treatments for rare and complex diseases, we offer a broad portfolio of plasma medicines and care solutions across more than 80 countries, supported by approximately 17,000 employees, 230 BioLife donation centers, and state-of-the-art manufacturing facilities. This role involves overseeing global regulatory operations within PDT, ensuring compliance, process excellence, and strategic leadership in regulatory submissions and relationships with third-party vendors. Key Responsibilities:
Strategic oversight of global regulatory submissions for PDT products, ensuring timely and well-resourced execution. Lead global compliance initiatives and process improvements across the organization. Manage relationships with external vendors and collaborate with R&D and other functions on regulatory strategies. Provide leadership within the PDT Regulatory Affairs leadership team, influencing strategic, portfolio, and operational decisions. Qualifications:
Bachelor's degree required; scientific field preferred. 7-10 years of regulatory experience in pharma/biotech, with management experience. Expertise in global drug development regulations, submissions, and lifecycle management. Additional Information:
This position is based in Boston, MA, with a hybrid work model. The salary range is $208,200 - $327,140, complemented by comprehensive benefits including incentives, insurance, and retirement plans. Takeda is committed to diversity and equal opportunity in all aspects of employment. #J-18808-Ljbffr