I'm seeking a challenging position as a Regulatory Affairs Lead. With 15 years of experience in regulatory affairs for pharmaceuticals and medical devices, I have developed effective processes and executed various initiatives. I am skilled in regulatory submissions and compliance management, using my regulatory knowledge to navigate complex environments and create robust strategies. My track record includes effective collaboration with cross-functional teams, and I consistently maintain an up-to-date understanding of regulatory requirements.
Responsible for managing the preparation and submission of product registrations and amendments and performing pharmacovigilance activities relating to pharmaceutical products and medical devices (class 1-4) for ophthalmic and aesthetics.
Regulatory strategy
Regulatory intelligence
Product lifecycle management
Labeling compliance
Leadership skills
Teamwork and collaboration
GxP knowledge