Regulatory Manager / Senior Regulatory Manager

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join their team. The successful candidate will provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities.

Requirements

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
• 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
• Computer literacy (MS Office/ Office 365)
• Fluent in English
• Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
• Availability for domestic and international travel including overnight stays