Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements
Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff
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