Remote Regulatory Manager Job in UK Precision For Medicine

Who you are

• Bachelor's degree in a scientific or healthcare discipline required.
• Minimum 5 years of regulatory experience at the Manager level, 7 years for the Senior Manager level.
• Must be fluent in English with solid computer literacy.
• Experience in regulatory affairs at a Clinical Research Organisation required.
• Knowledge of regulatory activities for EU or US.
• Ability to interpret clinical and pre-clinical study results for regulatory strategy.
• Available for domestic and international travel.

Desirables

• Graduate degree
• Postgraduate degree

What the job involves

• Provides regulatory guidance throughout the clinical development life cycle.
• Compile, review, and coordinate applications to regulatory authorities.
• Develop and review documents for compliance with regulatory standards.
• Serve as Global Regulatory Affairs representative at team meetings.
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets.
• Maintain project plans and trackers to keep leadership informed.
• Develop regulatory strategy and provide ICH GCP guidance.

Application process

• Application review
• Interview process
• Formal job offer