The Senior Manager of Regulatory Affairs oversees compliance initiatives ensuring all company procedures and products adhere to state and federal regulatory requirements
Job Summary
The Senior Manager of Regulatory Affairs oversees compliance initiatives ensuring all company procedures and products adhere to state and federal regulatory requirements.
This role involves leading complex international product programs by developing regulatory strategies for global clinical development and marketing applications.
The position requires directing the development of international product labels while negotiating with cross-functional teams to define commercial objectives.
Matching Summary
The Senior Manager of Regulatory Affairs oversees compliance initiatives ensuring all company procedures and products adhere to state and federal regulatory requirements.
Skills & Requirements
Must-have
International regulatory strategy development
Global clinical trial submission management
Labeling strategy and negotiation expertise
Nice-to-have
Cross-functional team collaboration skills
Process improvement initiative support
Mentoring junior regulatory leads
Key Requirements
Doctorate or Master's degree in scientific area
6 to 8 years of directly related experience
In-depth knowledge of regional medicinal product legislation