Otsuka America Pharmaceutical Inc.
Otsuka America Pharmaceutical Inc. is hiring a Senior Manager, Global Regulatory Affairs in Boston, Suffolk County, to help shape and advance the regulatory pathways that bring investigational and marketed prescription medicines to patients worldwide.
About the Role
As a Senior Manager, Global Regulatory Affairs at Otsuka America Pharmaceutical Inc., you will deliver essential support across the development and execution of global regulatory strategy for both investigational and commercialized prescription drug products. Working in close partnership with the Global Regulatory Lead, you will steward lifecycle activities for assigned projects and interpret the evolving requirements that govern submissions across multiple international markets. This full-time, on-site position is based in Boston, Suffolk County.
Key Responsibilities
- Contribute to the design and rollout of global regulatory strategy for assigned investigational and marketed prescription drug programs.
- Support the planning, preparation, and submission of worldwide regulatory filings in coordination with the Global Regulatory Lead.
- Manage product lifecycle activities across all assigned projects, keeping each aligned with broader regulatory objectives.
- Interpret intricate and shifting global regulatory requirements relevant to each program.
- Evaluate potential regulatory hurdles and communicate clear assessments of the associated risks and challenges.
Qualifications
- Demonstrated experience in global regulatory affairs within the pharmaceutical or biotechnology sector.
- Working knowledge of submission processes for investigational and marketed prescription drugs across international jurisdictions.
- Ability to analyze complex regulatory frameworks and translate them into practical, actionable guidance.
- Strong collaboration skills, with a record of partnering effectively alongside regulatory leadership.
- Excellent written and verbal communication for conveying regulatory strategy and risk assessments to diverse stakeholders.
About Otsuka America Pharmaceutical Inc.
Otsuka America Pharmaceutical Inc. is committed to developing and delivering innovative prescription therapies that improve the lives of patients around the world. Its regulatory affairs teams play a pivotal part in navigating the demanding requirements that bring new treatments to market responsibly and efficiently.
How to Apply
Ready to advance your career as a Senior Manager, Global Regulatory Affairs in Boston, Suffolk County? View the full listing and apply via Adzuna.
To apply for this job please visit www.adzuna.com.
Working in Boston, MA
Boston is the capital and most populous city of the U.S. state of Massachusetts. It serves as a cultural and financial center of New England, a region of the Northeastern United States. Boston has an area of 48.4 sq mi (125 km2) and a population of 675,647 as of the 2020 census, making it the third-most populous city in the Northeastern United States after New York City and Philadelphia. The larger Greater Boston metropolitan statistical area had a population of 4.9 million in 2023, making it the largest metropolitan area in New England and the eleventh-largest in the United States.
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