RA RIB Surveillance Specialist
HybridHyderabad, Telangana, India
Job Summary
Conduct worldwide regulatory intelligence surveillance for FDA, EMA, MHRA, and other global health authorities to pre-assess business impact across Lonza's CDMO offerings. Synthesize complex regulatory trends into actionable summary reports and partner with global Regulatory SMEs to determine operational applicability. Facilitate cross-functional intelligence assessment meetings, track resulting action items, and maintain regulatory databases using Power BI or Tableau. Monitor guidance documents and Q&A texts to distill requirements while building an internal library of regulatory knowledge. Work primarily in the office with 20% remote flexibility during EU business hours. This role supports Lonza's global business operations by proactively identifying regulatory risks and opportunities within the pharmaceutical industry.
Required Qualifications
- 5+ years of pharmaceutical industry experience
- Degree (Bachelor's or higher) in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or relevant equivalent practical industry experience
- Working knowledge of global regulatory frameworks, guidelines, and health authority expectations (FDA, EMA, MHRA, PMDA, ICH, PIC/S)
- Exceptional analytical and synthesis skills with a demonstrated ability to distill complex regulatory text into practical recommendations
- Experience with BI/dashboard tools (Power BI, Tableau) or regulatory surveillance platforms
- Ability to work EU business hours
- Strong organizational, project planning, and task-tracking abilities
- Proactive, hands-on learner with strong personal accountability, sound decision-making skills, and a commitment to transparent knowledge sharing
- Relocation assistance is available for eligible candidates and their families, if needed
- This is an office-first role
- You will work primarily in the office, with the flexibility to work remotely for 20% of your time (three days per week in office)
Desired Qualifications
- direct Regulatory Intelligence experience within pharma or biotech
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