Associate Director, Regulatory Submissions

Job Summary :

As our activities in Latin America are developing rapidly, we are currently looking for a full-time, office-based, Associate Director, Regulatory Submissions, based in Sao Paulo, Brazil to join our Site Activation & Maintenance team.

This position will allow you to join a key team in the success of the company.

If you want to develop your career in a stimulating environment, promote your experience and go even further, this position represents a real opportunity for you.

Responsibilities :

• Direct all operations of Regulatory Submissions department;
• Oversee hiring, training, evaluation, and retention of employees;
• Maintain departmental Standard Operating Procedures (SOPs);
• Provide oversight to Regulatory Submissions personnel;
• Evaluate departmental capacity needs on an ongoing basis and coordinate / delegate efficiently and in accordance with given timelines;
• Manage and provide accountability of the start-up and maintenance phases of global programs across all regions and various therapeutic areas;
• Serve as a primary Sponsor contact for all start-up specific issues and study deliverables;
• Maintain a thorough knowledge of country start-up processes and requirements;
• Oversee the progression of site activations ensuring quality, accuracy, and timeliness for assigned projects; and
• Manage risk assessment and related mitigation strategy execution related to study start-up.

Qualifications :