Regulatory Affairs Specialist

תיאור משרה

Join Our Regulatory Affairs Team: Shape the Future of Approved Biological Products
Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in fast-paced environments where your expertise drives compliance and saving lives? If so, we invite you to join our top-tier Regulatory Affairs (RA) team and help us bring life-changing biological products to patients worldwide.

About the Role
As a Regulatory Affairs Specialist, you will be at the heart of our mission—leading the end-to-end setup and management of regulatory submissions across multiple countries, including the US and Canada. Your professional insights will ensure our submissions are clear, compliant, and delivered with integrity. You'll collaborate with multidisciplinary teams, communicate with health authorities, and play a pivotal role in our global regulatory strategy.

What You'll Do

Lead Regulatory Submissions: Take ownership of regulatory submissions from start to approval, navigating diverse international requirements and ensuring our products meet the highest standards.
Drive Compliance: Stay ahead of evolving regulatory guidelines and champion best practices within the organization.
Craft and Review Documentation: Prepare and review submission materials, working closely with colleagues from various departments to deliver comprehensive, high-quality submissions.
Global Collaboration: Envolve with health authorities communications and expert consultancies worldwide, building relationships that support our regulatory success.