Job Description
Are you ready to drive the future of healthcare through data-driven insights? BioGenix Innovations, a leading biotechnology firm headquartered in the heart of Zurich, is seeking a highly skilled Senior Pharmaceutical Data Analyst to join our elite Regulatory Affairs team.
In this pivotal role, you will bridge the gap between complex clinical data and regulatory compliance, ensuring our groundbreaking therapies meet the highest global standards. We offer a competitive salary, comprehensive benefits, and an environment that fosters innovation and professional growth.
Why Join Us?
- Work with cutting-edge technology and proprietary data systems.
- Collaborate with world-renowned scientists and regulatory experts.
- Flexible working models and a commitment to work-life balance.
Take the next step in your career with a company that is literally saving lives.
Responsibilities
- Regulatory Submission Management: Lead the preparation and submission of eCTD documents for EMA and FDA submissions, ensuring 100% data integrity and compliance.
- Data Analysis & Modeling: Utilize statistical software (SAS, R, or Python) to analyze clinical trial datasets, generating comprehensive reports for internal stakeholders and regulators.
- Compliance Auditing: Conduct internal audits to ensure adherence to Good Manufacturing Practices (GMP) and data protection regulations (GDPR).
- System Optimization: Manage and optimize our Veeva Vault and SAP systems, streamlining data workflows to increase efficiency.
- Stakeholder Communication: Serve as the primary point of contact for cross-functional teams regarding data discrepancies and submission timelines.
- Trend Analysis: Monitor global regulatory trends and competitor activities to provide strategic recommendations for product lifecycle management.
Qualifications
- Education: Master’s degree in Pharmacy, Bioinformatics, Biostatistics, or a related Life Sciences field.
- Experience: Minimum of 5 years of experience in Pharmaceutical Regulatory Affairs or Clinical Data Management.
- Technical Proficiency: Advanced knowledge of regulatory submission software (Veeva Vault preferred) and SQL databases.
- Regulatory Knowledge: Deep understanding of ICH guidelines, FDA 21 CFR Part 11, and EMA procedures.
- Language Skills: Excellent command of English and German (written and verbal) is mandatory.
- Problem Solving: Strong analytical mindset with the ability to troubleshoot complex data issues under tight deadlines.