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
Responsibilities Review study budgets and costing regarding contract negotiation.
Participate in business development activities, prepare regulatory sections of proposals and feasibility reports, and attend bid defense meetings. Coordinate and manage regulatory and ethics committee submissions across EMEA, Asia Pacific and Latin America, ensuring accurate compilation, management and tracking of approvals.
Effectively communicate the status of submissions with sponsors, project managers, CRAs and Medical & Scientific Affairs staff. Contribute to the preparation of technical documentation such as IMPDs an
