סקירה כללית
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. What We’re Looking For * Education: M.Sc. or higher in Life Sciences. * Experience: 2–3 years in regulatory affairs within the pharmaceutical industry; experience with biological products is a plus. * Skills: Exceptional scientific writing, strong computer proficiency, and meticulous attention to detail. Ability to manage multiple projects simultaneously. * Communication: Outstanding English skills (written and verbal). Comfortably working independently and as part of a collaborative team. * Mindset: A team player personnel, proactive, solution-oriented attitude, integrity, and a passion for delivering results. Why Choose Us? * Industry Leadership: Work at the forefront of Israel’s unique plasma pharmaceutical and manufacturing sector, contributing to products that save lives globally. * Collaborative Culture: Join a mission-driven team where every member’s contribution is valued and visible. * Professional Growth: Expand your expertise in regulatory affairs, gain exposure to international markets, and develop your career in a supportive, innovative environment. Ready to make a difference? Apply now and become part of a team that’s shaping the future of healthcare through regulatory excellence.
דרישות המשרה
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
