דרושים » רפואה ופארמה » Regulatory Affairs Specialist - Israel R52900

Take on a pivotal role as a Regulatory Affairs Specialist in Israel, supporting both pre-market and post-market regulatory activities within our companys Diabetes spin-off organization. In this role, you will be a key partner to cross-functional teams, ensuring regulatory compliance across the product lifecycle while enabling timely market access and sustaining ongoing business operations. This is an exciting opportunity to contribute to a growing, agile organization focused on innovation and delivering impactful solutions for people living with diabetes.
This position is an exciting opportunity to work with our company's Diabetes business. our company has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across our company, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Responsibilities may include the following and other duties may be assigned:
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.