Das ist der Job
Provide expert regulatory advice and contribute to regulatory project work.
Darum lohnt es sich
As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations.
What The Regulatory Affairs Department Does At The Worldwide
Regulatory Affairs plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials.
Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission process.
What You Will Do Review study budgets and costing for 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 and manage regulatory and ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions, ensuring accurate compilation, management and tracking of submissions. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff.
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