Regulatory Compliance Expert
vor 14 Stunden
We are CSL Behring, a global leader in the development and delivery of high-quality medicines that treat rare and serious diseases. Our commitment to saving and improving lives drives us to push the boundaries of innovation and excellence.
About the RoleWe are seeking a highly skilled Regulatory Compliance Expert to join our Global Regulatory Affairs team. As a key member of our team, you will play a critical role in ensuring our organization's adherence to regulatory compliance, procedural documents management, training, compliance activities, reporting and analytics, and other critical functions.
Key Responsibilities- Procedural Documents Management: Support procedural document preparation, review, and lifecycle management. Ensure compliance with local and global procedural documents, and maintain the company online glossary with GRA definitions.
- Training: Conduct training analysis and assignment, maintain training presentations, onboard newcomers to the department, facilitate classroom training sessions, and support annual reviews of training curricula.
- Compliance Activities: Support regulatory agency inspections and audits, including pre-inspection and related follow-up activities. Manage eStaff Record filing repository, track audits & inspections performed in GRA, and support management of quality non-compliance events in GRA.
- Reporting and Analytics: Prepare and/or review various compliance reports and monitor compliance indicators.
To succeed in this role, you will need:
- Education: Bachelor degree in a Life Science or Business, Advanced degree in a Life Science (PhD, MD) or Business (MBA) is an advantage.
- Experience: 1+ years of regulatory experience in the pharmaceutical industry, Biologics Regulatory experience preferred.
- Language: English is essential, and German is nice to have.
We offer a competitive salary of $80,000 - $110,000 per year, depending on experience, and a comprehensive benefits package that includes health insurance, retirement plan, and paid time off. We also offer opportunities for professional growth and development, a dynamic and supportive work environment, and a collaborative team culture.
About CSL BehringCSL Behring is a global organization with employees in 35+ countries, and we are committed to diversity and inclusion. We are a leader in the development and delivery of high-quality medicines that treat people with rare and serious diseases. Learn more about CSL Behring and our commitment to patients and the community.
Join Our TeamIf you are passionate about regulatory compliance and eager to make a difference in the lives of patients, we encourage you to apply for this exciting opportunity. We are an equal opportunities employer and welcome applications from diverse candidates. Please submit your application, including your resume and a cover letter, to our online portal.
Estimated Salary: $95,000 - $120,000 per year-
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