Global Regulatory Strategy Manager
vor 2 Wochen
Overview
We are a leading staffing agency specializing in placing top talent in the pharmaceutical industry. Our goal is to connect professionals like you with exciting opportunities that match your skills and interests.
About This Opportunity
We are seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our growth and emerging markets team, you will be responsible for developing and implementing regulatory strategies that drive business success.
Main Responsibilities
- Develop Regulatory Strategies: Collaborate with cross-functional teams to develop and implement regulatory strategies that maximize market access and compliance.
- Manage Submission Planning and Execution: Independently manage and execute all aspects of submission planning and execution, ensuring timely approval of investigational applications and market applications.
- Provide Regulatory Expertise: Provide regulatory expertise on marketed products in growth and emerging markets, focusing on non-clinical and clinical aspects of registration and post-marketing compliance.
- Collaborate with Cross-Functional Teams: Develop effective working relationships with local regulatory leads, regional and global regulatory teams, and cross-functional teams to ensure seamless communication and collaboration.
Requirements
- Bachelor's degree in a scientific discipline or equivalent experience.
- Considerable experience within the pharmaceutical industry, including direct experience in regulatory affairs in development and/or post-marketing phases.
- Solid regulatory experience, including knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets.
- Preferred experience in managing major regulatory filings and significant contributor to regulatory and/or development strategies.
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