Senior Manager, Global Regulatory Affairs, CMC Small Molecules Join Takeda as a Senior Manager, Global Regulatory Affairs, CMC Small Molecules, where you will oversee the development and execution of regulatory CMC development and registration strategies.

Is this your next job Read the full description below to find out, and do not hesitate to make an application. This range is provided by Takeda. Your actual pay will be based on your skills and experience. The base pay range is $137,000.00/yr - $215,270.00/yr. About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As a Senior Manager, Global Regulatory Affairs, CMC Small Molecules, you will be responsible for: Planning, executing, and managing regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities. Providing regulatory CMC expertise for new business development/due diligence activities. Communicating and negotiating with international Health Authorities as necessary, directly and indirectly. Representing Takeda RA CMC in Health Authority meetings and leading or supporting CMC preparation activities for meetings with Health Authorities on CMC related matters. Mentoring and developing staff, including staff professional development and project oversight accountability. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. Ideal candidate has 6 years of related experience, preferably with 4 years in regulatory. Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws.

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