Summary
The role provides leadership to areas of responsibility on complex regulatory affairs activities including regulatory submissions and labeling and to provide support on any regulatory affairs matters required for commercial operations.
Is responsible to lead regional regulation review process, providing guidance to the organization with respect to health authority expectations and requirements; preparing, submitting and negotiating with global and regional regulatory bodies to obtain approval or clearance of premarket registration as well as post market compliance.
The below job description is not intended to be exhaustive, additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.
Your Responsibilities
Compliance
You are expected to adhere through your conduct to all applicable laws and regulations as well as to the high integrity standards as set forth by Roche.
Who You Are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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