shionogi
The Senior Manager, Regulatory Affairs CMC provides strategic support and coordination for Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities under the guidance of the Senior Director, CMC. This role involves collaborating with cross-functional teams and regulatory authorities to ensure compliance and drive the success of Shionogi’s pipeline products and initiatives. The position requires developing regulatory strategies, overseeing CMC-related document submissions, and serving as a key contact for regulatory agencies.
Headquarters
Florham Park, New Jersey, United States
Company Size
501-1000 employees
Founded
2001
Shionogi Inc. is a discovery-based pharmaceutical company dedicated to developing, partnering, and commercializing medicines to address serious unmet medical needs. It advances a diverse pipeline through internal R&D, clinical trials, and collaborations, including programs for rare diseases (e.g., Fragile X syndrome) and other therapeutic areas. The company emphasizes transparency, sustainability, patient advocacy, and support for investigators through grants and expanded-access policies. Leveraging global resources and partnerships, Shionogi works to bring novel therapies to patients and healthcare stakeholders.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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