RA RIB Surveillance Specialist
About this role
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A variety of benefits dependent on role and location.
- The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.
- Global Impact: Conduct worldwide regulatory intelligence surveillance (FDA, EMA, MHRA, PMDA, Health Canada, ICH, PIC/S) to pre-assess potential business impact across Lonza’s CDMO offerings.
- Stakeholder Collaboration: Partner with global Regulatory Subject Matter Experts (SMEs), Quality, and cross-functional teams to review updates and determine operational applicability.
- Surveillance & Analysis: Monitor regulatory updates, guidance documents, and Q&A texts, converting complex regulatory requirements into clear, actionable summary reports.
- Action & Meeting Leadership: Facilitate cross-functional intelligence assessment meetings, record decisions, and open and track resulting regulatory action items to completion.
- Data Management & Dashboards: Maintain regulatory intelligence databases, dashboards, and metrics (Power BI/Tableau) to ensure global visibility and audit readiness.
- Knowledge Enablement: Maintain an indexed library of regulatory guidance and assist in developing internal training materials to build regulatory intelligence capabilities across the network.
- Operational Alignment: Continuously expand knowledge of Lonza’s business activities to proactively identify regulatory risks and opportunities.
- Industry Experience: 5+ years of pharmaceutical industry experience; direct Regulatory Intelligence experience within pharma or biotech is strongly preferred.
- Education & Transferable Knowledge: Degree (Bachelor's or higher preferred) in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or relevant equivalent practical industry experience.
- Regulatory Expertise: Working knowledge of global regulatory frameworks, guidelines, and health authority expectations (FDA, EMA, MHRA, PMDA, ICH, PIC/S).
- Analytical Capability: Exceptional analytical and synthesis skills with a demonstrated ability to distill complex regulatory text into practical recommendations.
- Technical Skills & Working Hours: Experience with BI/dashboard tools (Power BI, Tableau) or regulatory surveillance platforms; ability to work EU business hours.
- Project Management: Strong organizational, project planning, and task-tracking abilities.
- Attributes: Proactive, hands-on learner with strong personal accountability, sound decision-making skills, and a commitment to transparent knowledge sharing.
Company at a glance
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
Top Benefits
- Relocation assistance
- Agile career culture
- Inclusive workplace
- Compensation programs
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