Lonza—Regulatory Intelligence Senior Specialist

Job description

Description: 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 benefits 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 (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. What we are looking for: - 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. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.