Senior Manager, CMC Global Regulatory Affairs

Otsuka America Pharmaceutical Inc. is hiring a Senior Manager, CMC Global Regulatory Affairs in Tallahassee, Leon County for a full-time position. You'll lead Chemistry, Manufacturing and Controls regulatory strategy across our global portfolio, shaping how we navigate compliance and innovation from development through commercial success.

The Opportunity

This senior regulatory leadership role focuses on developing and executing comprehensive CMC regulatory strategies for small molecule and biological products. You'll oversee the regulatory path for compounds in late-stage development and mature commercial products, managing everything from initial regulatory submissions to post-approval modifications. Your strategic insights will influence how our organization approaches manufacturing compliance, control strategies, and global regulatory requirements across multiple markets and product types.

Core Duties

• Design and implement global regulatory strategies for CMC components of pharmaceutical and biotechnological products
• Lead preparation and submission of chemistry, manufacturing, and controls information for marketing applications and regulatory filings
• Manage post-approval regulatory activities, including supplements and variation submissions across international markets
• Oversee cross-functional coordination between manufacturing, quality, and regulatory teams to ensure compliance
• Represent CMC regulatory interests in global product development meetings and lifecycle planning discussions
• Monitor evolving global regulatory requirements and implement necessary updates to strategies and processes

Who We're Looking For

• Advanced degree in pharmacy, chemistry, chemical engineering, or life sciences discipline
• Demonstrated expertise in CMC regulatory affairs, preferably in a pharmaceutical or biotech setting
• Extensive knowledge of global regulatory requirements (FDA, EMA, ICH guidelines)
• Proven experience managing regulatory submissions and post-approval changes
• Strong project management and cross-functional leadership capabilities
• Excellent communication skills for diverse audiences including regulatory agencies and internal stakeholders

Why Join Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. is a respected innovator in the pharmaceutical industry. This role offers you the opportunity to impact drug development and patient access on a global scale, working with both small molecule and advanced biotechnological products in a dynamic regulatory environment. You'll collaborate with talented professionals across functions and geographies to advance our mission.

Next Steps

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.