The Manager, Regulatory Affairs will support global development programs in collaboration with key stakeholders. Reporting to the Senior Vice President, Regulatory Affairs, you will support regulatory activities and contribute to department initiatives. This position will focus on clinical trial applications (CTAs).

The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements.

In this role, you will support AG1 growth by ensuring that products are manufactured, labeled, and marketed in compliance with all applicable regulations and laws, primarily in the EU, UK, and other key global regions, while also supporting US regulatory activities as needed.

In this role, you will manage all aspects related to Regulatory Affairs and Pharmacovigilance in connection with Expanded Access Programs (EAPs). This includes developing regulatory strategies, consulting clients, and managing complex projects to ensure EAPs are executed according to plan and in compliance with regulatory requirements and client expectations. Be a leader in a growing company.

Drive customer success with Veeva Regulatory Information Management (RIM) products in Europe, supporting software product management, specializing in Submissions, Submissions Archive and Publishing applications, advocating the voice of the customer, and shaping the product roadmap to support regulatory document management. You'll represent the Product organization in customer meetings and industry events and create valuable resources for both internal and external stakeholders.