02 Oct
|
Lonza
|
Hyderabad
Job Title: Regulatory Intelligence Senior Specialist
Location: The actual location of this job is in Hyderabad, India. Relocation assistance is available for eligible candidates and their families, if needed.
Step into a vital role in Hyderabad, India, driving global regulatory intelligence to monitor and pre-assess changing health authority requirements across human and veterinary medicines worldwide. In this position, you will synthesize complex regulatory trends to safeguard compliance and support Lonza's global business operations.
This is an office-first role. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (three days per week in office).
What you will get:
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A variety of advantages dependent on role and location.
- The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do:
- 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 (Pow
📌 Regulatory Intelligence Senior Specialist (Hyderabad)
🏢 Lonza
📍 Hyderabad