(Senior) Regulatory Manager

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Requirements:

• Bachelor's degree or equivalent experience in a scientific or healthcare discipline.
• 5 years of regulatory experience required for Manager level, 7 years for Senior Manager level.
• Computer literacy in MS Office/Office 365.
• Fluent in English.
• Experience working for a Clinical Research Organisation.
• Informed knowledge of drug development and regulatory milestones.
• Understanding clinical and pre-clinical study results.
• Knowledge of clinical trials methodology.
• Expertise with relevant regulations and guidance.
• Availability for domestic and international travel.

Responsibilities:

• Provide regulatory guidance throughout the clinical development life cycle.
• Compile, coordinate and review applications to Regulatory Authorities.
• Develop and/or review documents for submission to Regulatory Authorities and/or Ethics Committees.
• Serve as representative of Global Regulatory Affairs at project team meetings.
• Oversee and coordinate Regulatory Affairs Specialists.
• Maintenance of project plans and regulatory intelligence tools.
• Assist in development of Regulatory Affairs Specialists.
• Provide input into regulatory strategy for new study opportunities.
• Participate in maintaining corporate quality initiatives.
• Keep abreast of laws, regulations, and guidelines.
• Provide ICH GCP guidance and training to clients.
• Represent Global Regulatory Affairs at business development meetings.