Regulatory Affairs Manager

Primary Job Function/Mission

Regulatory Strategy and Compliance

• Develop and implement new assets regulatory strategies for the assigned product portfolio with the most competitive label in line with business/R&D objectives incompliance with local, regional, and international regulations. Coordinates the internal preparation, rehearsal and readiness for the local Health Authority meeting (New Molecular Committee).
• Oversee the implementation of regulatory maintenance strategy for the assigned product portfolio.

Documentation and submissions management

• Oversee the preparation and submission of regulatory documents for new assets such as new drug applications (NDAs) and marketing authorization applications for devices (MAAs) and ensure that all regulatory maintenance preparation and submissions follow the applicable regulatory guidelines and standa...